FDA Device Recall Z-0003-2019: Smith & Nephew, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-2019.

Recall Res Number

Z-0003-2019

Recalling Firm / Manufacturer

Smith & Nephew, Inc.

FEI Number

1020279

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2018-06-13

Date Posted

2018-10-01

Date Terminated

N/A

Product Code

JWH

Event Number

80313

Product Quantity

64642

Product Description JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

Reason for Recall The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

Action Details The Field Safety Notice (FSN) sent to risk managers on 06/13/2018 asks customers to inspect inventory, locate and quarantine affected, unused Journey BCS Knee CoCr Femoral Components and JOURNEY BCS OXINIUM Knee Femoral Components. Affected product subject of the voluntary removal is to be returned to Smith & Nephew. All consignees are asked to complete an FSN Response Form, even if they do not have product to return. The Field Safety Notice, communicated with surgeons that these first generation JOURNEY BCS tibial inserts should only be used for polyethylene exchange revision of the first generation JOURNEY BCS total knee constructs where the femoral component and tibial baseplate are well-fixed. This notification, addressed to implanting surgeons, requesting their receipt and acknowledgement of the FSN.

Distribution Pattern Worldwide distribution, including US nationwide and Puerto Rico, Austria, United Arab Emirates, Australia, Belgium, Canada, China, Switzerland, Germany, Denmark, Finland, France, Great Britain, India, Spain, Italy, Netherlands, Portugal, Sweden, Venezuela, South Africa.

Code Information / Serial Numbers All lots

Related Establishments / Registrations

Paragon Medical - Dayton Registration: 1000200989 View Registration
STERLAB Registration: 1000286794 View Registration
Paragon Medical Inc. Registration: 1000517406 View Registration
IMPLANTS INTL. LTD. Registration: 1000547811 View Registration
MARSON MEDICAL, INC. Registration: 1000550978 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
SMITH & NEPHEW, INC. Registration: 1020279 View Registration
EXACTECH, INC. Registration: 1038671 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
SOUTHEASTERN TECHNOLOGY dba Autocam Medical Registration: 1057425 View Registration
INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration
ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
Viant AS&O Holdings, LLC Registration: 1218882 View Registration
SMITH & NEPHEW INC. Registration: 1219602 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1219655 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
SYMMETRY MEDICAL, INC. - MANCHESTER Registration: 1221053 View Registration
ARCH Medical Solutions - Seabrook Registration: 1221763 View Registration
JARVIS SURGICAL INC. Registration: 1223434 View Registration
OMNIlifeScience, Inc. Registration: 1226188 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
Oberg Medical - XL Division Registration: 1422549 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
APS MATERIALS, INC. Registration: 1529009 View Registration
HAMMILL MFG. CO. Registration: 1530390 View Registration
NORWOOD MEDICAL LLC Registration: 1531174 View Registration
SMITH & NEPHEW INC. Registration: 1643264 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
CENTEX MACHINING, INC. Registration: 1645151 View Registration
Micron Solutions, Inc. Registration: 1646498 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
ORTHO DEVELOPMENT CORP. Registration: 1722511 View Registration
MEDICAL MODELING - A 3D SYSTEMS COMPANY Registration: 1724955 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1818910 View Registration
ZIMMER, INC. Registration: 1822565 View Registration
BIOMET, INC. Registration: 1825034 View Registration
ORCHID ORTHOPEDICS-CHELSEA Registration: 1827096 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration
Viant AS&O Holdings, LLC Registration: 1832228 View Registration
BIOPRO, INC. Registration: 1833506 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
PRECISION EDGE SURGICAL PRODUCTS COMPANY Registration: 1833986 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
NGInstruments, Inc dba Avalign Cutting Instruments Registration: 1835251 View Registration
Avalign Delivery Systems Division Registration: 1835444 View Registration
MAITLAND ENGINEERING Registration: 1835572 View Registration
C+A TOOL ENGINEERING, INC. Registration: 1836357 View Registration
Freudenberg Medical, LLC Registration: 2025182 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
PRO-TECH DESIGN & MFG., INC. Registration: 2032521 View Registration
Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
LOWELL,INC. Registration: 2134470 View Registration
GAUTHIER BIOMEDICAL, INC. Registration: 2134947 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
RMS CO. Registration: 2183946 View Registration
KEN-MAR MACHINE MFG CORP Registration: 2242737 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Isomedix Operations Inc. Registration: 2246552 View Registration
SCT, INC. Registration: 2249615 View Registration
HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
ARCH - Quakertown Registration: 2531477 View Registration
ZIMMER MANUFACTURING B.V. Registration: 2648920 View Registration
MACK MOLDING COMPANY Registration: 3000236920 View Registration
ORTHOPLASTICS LTD Registration: 3000264985 View Registration
SPANG & BRANDS GMBH Registration: 3002558847 View Registration
STERIS SPA Registration: 3002806470 View Registration
STERIS SPA Registration: 3002806603 View Registration
GREENPIA TECHNOLOGY INC. Registration: 3002807112 View Registration
IONISOS Registration: 3002807295 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
SYNERGY HEALTH STERILISATION UK LTD Registration: 3002807315 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
Phillips Precision Inc Registration: 3003387384 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
T & L SHARPENING, INC. Registration: 3003541440 View Registration
OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
LABORATORIOS SL SA Registration: 3003916006 View Registration
MATERIALISE N.V. Registration: 3003998208 View Registration
GLOBUS MEDICAL, INC. Registration: 3004142400 View Registration
ConforMIS, Inc. Registration: 3004153240 View Registration
DONSON MACHINE COMPANY Registration: 3004153896 View Registration
SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD Registration: 3004196040 View Registration
Waldemar Link GmbH & Co. KG Registration: 3004371426 View Registration
HONER Medizin-Technik GmbH & Co. KG Registration: 3004450489 View Registration
FIVE STAR MANUFACTURING, INC. Registration: 3004513872 View Registration
PURACON GMBH Registration: 3004638532 View Registration
ENZTEC LIMITED Registration: 3004641308 View Registration
SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration
Viant Medical, LLC Registration: 3004976965 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
EPTAM PLASTICS, LTD Registration: 3005144609 View Registration
MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration
Mack Proto Registration: 3005279746 View Registration
MEDICAL CONTENEUR SAS Registration: 3005360851 View Registration
SMITH & NEPHEW, INC. Registration: 3005551626 View Registration
BGS Beta-Gamma-Service GmbH & Co KG Registration: 3005562917 View Registration
Nelipak Healthcare Packaging Registration: 3005581234 View Registration
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. Registration: 3005596372 View Registration
HUNT DEVELOPMENTS (UK) LIMITED Registration: 3005652161 View Registration
Materialise USA, LLC. Registration: 3005718816 View Registration
Zimmer Trabecular Metal Technology, Inc. Registration: 3005751028 View Registration
ORCHID ORTHOPEDIC SOLUTIONS LANSING Registration: 3005852519 View Registration
ARCH-MedTorque Registration: 3005874553 View Registration
ADVANCED CONCEPT INNOVATIONS LLC Registration: 3006015326 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
Nemcomed FW LLC Registration: 3006128100 View Registration
JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Registration: 3006356043 View Registration
CANWELL MEDICAL CO., LTD. Registration: 3006395932 View Registration
Heraeus Medical GmbH Registration: 3006406161 View Registration
GSELL MEDICAL PLASTICS AG Registration: 3006487372 View Registration
CEFIMECA Registration: 3006563559 View Registration
CREATEC GmbH & CO. KG Registration: 3006694268 View Registration
ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS Registration: 3006791286 View Registration
Zhejiang Biomet Medical Products Co., Ltd. Registration: 3006801265 View Registration
MEDISTRI SA Registration: 3006946276 View Registration
TAKUMI PRECISION ENGINEERING LTD Registration: 3007189546 View Registration
SFERIC Registration: 3007200272 View Registration
MAXX ORTHOPEDICS INC. Registration: 3007311878 View Registration
CPM Medical Consultants, LLC. Registration: 3007334927 View Registration
LINCOTEK TRENTO S.P.A Registration: 3007353762 View Registration
Smith & Nephew, Inc. Registration: 3007366790 View Registration
Trilliant Surgical LLC Registration: 3007420745 View Registration
PT. TEAM METAL INDONESIA Registration: 3007516837 View Registration
Paragon Medical Device (Changzhou) Co., Ltd. Registration: 3007539489 View Registration
IMPLANET Registration: 3007675554 View Registration
Stryker (Suzhou) Medical Technology Co.,Ltd. Registration: 3007913880 View Registration
Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 View Registration
Zimmer Orthopedic Mfg Ltd Registration: 3007963827 View Registration
Limacorporate S.p.A. Registration: 3008021110 View Registration
Synergy Health Radeberg GMBH Registration: 3008102042 View Registration
MEDACTA INTERNATIONAL SA Registration: 3008110533 View Registration
SIGNATURE ORTHOPAEDICS PTY LIMITED Registration: 3008262872 View Registration
L&K BIOMED CO.,LTD. Registration: 3008285983 View Registration
Limacorporate S.p.A. Registration: 3008395353 View Registration
Lincotek Medical Registration: 3008421730 View Registration
TOTAL JOINT ORTHOPEDICS, INC. Registration: 3008544874 View Registration
Symmetry Medical Malaysia Sdn Bhd (758243-M) Registration: 3008572101 View Registration
Exactech Sarasota Registration: 3008658204 View Registration
Smith & Nephew, Inc. Registration: 3008744062 View Registration
LX PRECISION SHANGHAI CO LTD Registration: 3008791302 View Registration
Swann-Morton(Services) Limited Registration: 3008812251 View Registration
STERIS Sterilization Technologies (Suzhou) Ltd Registration: 3008824097 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
MATORTHO LIMITED Registration: 3008985661 View Registration
CORENTEC CO., LTD. Registration: 3009106092 View Registration
CARAGH PRECISION Registration: 3009173317 View Registration
TURNCO TOOL & INSTRUMENT, INC. Registration: 3009241418 View Registration
NSE-AUTOMATECH Registration: 3009293341 View Registration
LSM-MED S.r.l. Registration: 3009475821 View Registration
HPF S.R.L. Registration: 3009546990 View Registration
Materialise Ukraine, Rep. office Registration: 3009555440 View Registration
Materialise Sdn Bhd Registration: 3009555447 View Registration
Li Wai Precision International Limited Registration: 3009582259 View Registration
AMPLITUDE Registration: 3009590742 View Registration
STERIPACK USA (LIMITED) LLC Registration: 3009656988 View Registration
BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
UOC USA Inc. Registration: 3009760038 View Registration
SYMMETRY MEDICAL IRELAND LIMITED Registration: 3009813841 View Registration
ORCHID ORTHOPEDIC SOLUTIONS OREGON, INC. Registration: 3009848551 View Registration
SHEFFIELD PRECISION MEDICAL LTD Registration: 3009871135 View Registration
PERRYMAN COMPANY Registration: 3009882462 View Registration
Complexus Medical Registration: 3009887475 View Registration
Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration
Sites Medical, LLC Registration: 3009923578 View Registration
ARCH Medical Solutions - Warsaw Registration: 3009971621 View Registration
Engineered Medical Systems, LLC Registration: 3009973336 View Registration
ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration
Mendell Registration: 3009998573 View Registration
rms Surgical Registration: 3010009693 View Registration
Lincotek Medical LLC Registration: 3010039400 View Registration
ALMARK TOOL & MANUFACTURING COMPANY, INC. Registration: 3010041693 View Registration
CULVER TOOL & ENGINEERING Registration: 3010047454 View Registration
LH MEDICAL CORPORATION Registration: 3010057495 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
BRANCH MEDICAL GROUP Registration: 3010120104 View Registration
MEDTECH LLC Registration: 3010123256 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010132111 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010155661 View Registration
Synergy Health Marseille SAS Registration: 3010162973 View Registration
APPLIMED SA -CSSR Registration: 3010163695 View Registration
Synergy Health Westport Ltd Registration: 3010173425 View Registration
IONISOS Registration: 3010178296 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
BAECHLER FEINTECH AG Registration: 3010287737 View Registration
BGS Beta Gamma Service GmbH & Co KG Registration: 3010288357 View Registration
INNOTOOL&GREMINGER AG Registration: 3010314800 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
FRUEH VERPACKUNGSTECHNIK AG Registration: 3010363503 View Registration
SIMON SAS Registration: 3010370880 View Registration
PPD MEDITECH, DIV. OF INDUSTRIES PPD INC. Registration: 3010375065 View Registration
SINGLE SOURCE MEDICAL LLC Registration: 3010386387 View Registration
GUANGZHOU AQUILA PRECISE TOOLS LIMITED Registration: 3010388970 View Registration
YU XIN TECHNOLOGY(HUIZHOU) CO.,LTD Registration: 3010390570 View Registration
Aragogamma, S.L. Registration: 3010392243 View Registration
TRIBE MEDICAL GROUP Registration: 3010400367 View Registration
SIMAGEC Registration: 3010462278 View Registration
TRIGON INCORPORATED Registration: 3010468876 View Registration
PRO-TECH Design & Mfg, Inc. Registration: 3010531069 View Registration
MICROPORT ORTHOPEDICS INC. Registration: 3010536692 View Registration
OSTEOREMEDIES, LLC Registration: 3010537287 View Registration
SAS ETABLISSEMENTS MAURICE MARLE Registration: 3010576282 View Registration
MERIL HEALTHCARE PVT. LTD. Registration: 3010846112 View Registration
Microport Orthopedics, S.A. Registration: 3010856250 View Registration
G21 S.R.I. Registration: 3010898856 View Registration
INCIPIO DEVICES Registration: 3011015572 View Registration
Advanced Machine, Inc. Registration: 3011061242 View Registration
SURGTECH, INC. Registration: 3011170410 View Registration
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT Registration: 3011187779 View Registration
WESTLAKE PLASTICS EUROPE Registration: 3011274144 View Registration
Suzhou Elite Precision Machinery Co., Ltd. Registration: 3011295718 View Registration
DOT AMERICA, INC. Registration: 3011461101 View Registration
Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 View Registration
Materialise Colombia S.A.S Registration: 3011724582 View Registration
MicroPort Orthopedics Global Supply Center Limited Registration: 3012130008 View Registration
MARLE FINISHING SAS Registration: 3012275107 View Registration
Zimmer Orthopedics Manufacturing Limited-Galway Registration: 3012319330 View Registration
UNITED ORTHOPEDIC CORPORATION Registration: 3012329926 View Registration
Zimmer Biomet Canada DFE Registration: 3012392319 View Registration
Summit Orthopedic Technologies Inc. Registration: 3012491394 View Registration
implantcast GmbH Registration: 3012523063 View Registration
Zimmer Biomet G.K. Registration: 3012725451 View Registration
Stryker Anngrove Registration: 3013014058 View Registration
Biomet Global Supply Chain Center B.V. Registration: 3013055499 View Registration
ZIMMER PTE. LTD. Registration: 3013176080 View Registration
Heraeus Medical LLC Registration: 3013186738 View Registration
ARMBRUSTER GMBH Registration: 3013194153 View Registration
ARVATO Netherlands B.V. Registration: 3013302242 View Registration
Oberg Medical - Finishing Solutions Registration: 3013417938 View Registration
ONKOS SURGICAL, INC. Registration: 3013450937 View Registration
OEB S.R.L. Registration: 3013791180 View Registration
BEIJING AK MEDICAL CO, LTD Registration: 3013843055 View Registration
PRECISION ADM Registration: 3014162916 View Registration
C&A Tool Engineering, Inc. Auburn Plant Registration: 3014252644 View Registration
NOVOSOURCE, LLC Registration: 3014273644 View Registration
BIOMET CHILE S.A. Registration: 3014302784 View Registration
Zimmer Biomet Centroamerica SA Registration: 3014315560 View Registration
b-ONE Medical (Beijing) Co., Ltd. Registration: 3014644608 View Registration
SUZHOU MICROPORT ORTHORECON CO., LTD. Registration: 3014662844 View Registration
Signature Orthopaedics Europe Ltd Registration: 3014763043 View Registration
restor3d, inc. Registration: 3014833750 View Registration
B-ONE MEDICAL (SUZHOU) CO., LTD. Registration: 3015167917 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
B-ONE ORTHO, CORP. Registration: 3015259876 View Registration
Kyocera Medical Technologies, Inc. Registration: 3015398319 View Registration
Depuy Ireland UC Registration: 3015516266 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
I-MEDICAL ASIA COMPANY LIMITED Registration: 3015806723 View Registration
RESTORATION MEDICAL POLYMERS Registration: 3015916578 View Registration
Blue Belt Technologies, Inc. Registration: 3016090213 View Registration
MatOrtho Limited Registration: 3016096064 View Registration
ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
OPTIMOTION IMPLANTS, LLC Registration: 3016470314 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
EDDI BRESSAN S.R.L. Registration: 3017397663 View Registration
MAKO SURGICAL CORP. Registration: 3017410889 View Registration
AKSHAR GAMMA STERILES LLP Registration: 3018052045 View Registration
UNIK ORTHOPEDICS, INC Registration: 3019006180 View Registration
BRANCH MEDICAL GROUP Registration: 3019767615 View Registration
SHALBY ADVANCED TECHNOLOGIES, INC. Registration: 3020155054 View Registration
MACH MEDICAL Registration: 3020703621 View Registration
LINCOTEK MEDICAL, LLC Registration: 3020745236 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
STEROX SRL Registration: 3021566676 View Registration
Smith and Nephew Operations Sdn. Bhd Registration: 3022142628 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
STI LUALDI S.R.L. Registration: 3026771806 View Registration
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex) Registration: 3026776 View Registration
VALTECNE SPA Registration: 3027484613 View Registration
GLOBUS MEDICAL, INC. Registration: 3030412764 View Registration
SKYVE CO., LTD. Registration: 3030446955 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
CHANGZHOU WASTONORTHO MEDICAL APPLIANCE CO., LTD. Registration: 3033796901 View Registration
DePuy Synthes Sales Registration: 3034676720 View Registration
Zimmer Biomet Pty Ltd Registration: 3035366890 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
Smith & Nephew, Inc. Registration: 3038503932 View Registration
BEIJING IKEY MEDICAL DEVICE TECHNOLOGY CO., LTD. Registration: 3040391045 View Registration
NZ BIOMED LIMITED Registration: 3042172882 View Registration
b-ONE Ortho Corp. Registration: 3042508254 View Registration
DEPUY INTL., LTD. Registration: 8010379 View Registration
Kammerer Medical Systems GmbH & Co. KG Registration: 8010916 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
AESCULAP AG Registration: 9610612 View Registration
HOWMEDICA INTERNATIONAL S. DE R.L., Registration: 9610726 View Registration
FRIEDRICH DANIELS GMBH Registration: 9611390 View Registration
ZIMMER GMBH Registration: 9613350 View Registration
SMITH & NEPHEW ORTHOPAEDICS AG Registration: 9613369 View Registration
Corin Limited Registration: 9614209 View Registration
TECRES SPA Registration: 9614841 View Registration
DEPUY (IRELAND) Registration: 9616671 View Registration
STRYKER IRELAND OSTEONICS Registration: 9616680 View Registration
BIOCOMPOSITES LTD. Registration: 9617083 View Registration
ZIMMER CAS Registration: 9617840 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
AESCULAP SAS Registration: 9681258 View Registration
Gammatom S.r.l. Registration: 9681465 View Registration
UNITED ORTHOPEDIC CORP. Registration: 9681642 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0003-2019

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer