FDA Device Recall Z-0009-2008: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-2008.

Recall Res Number

Z-0009-2008

Recalling Firm / Manufacturer

N/A

FEI Number

1000116912

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-08-09

Date Posted

2007-10-10

Date Terminated

2008-03-10

Product Code

HRY

Event Number

38951

Product Quantity

5 units.

Product Description EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

Reason for Recall Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

Action Details Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.

Distribution Pattern Products distributed to direct accounts in CA, FL and MD.

Code Information / Serial Numbers All lots.

Related Establishments / Registrations

Paragon Medical Inc. Registration: 1000517406 View Registration
MARSON MEDICAL, INC. Registration: 1000550978 View Registration
SMITH & NEPHEW, INC. Registration: 1020279 View Registration
EXACTECH, INC. Registration: 1038671 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
SMITH & NEPHEW INC. Registration: 1219602 View Registration
DEPUY ORTHOPAEDICS, INC. Registration: 1219655 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
Instrumed International Inc dba Avalign German Specialty Instruments Registration: 1421101 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
APS MATERIALS, INC. Registration: 1529009 View Registration
SMITH & NEPHEW INC. Registration: 1643264 View Registration
ENCORE MEDICAL, L.P. Registration: 1644408 View Registration
Sterigenics US LLC Registration: 1649518 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
SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration
BIOPRO, INC. Registration: 1833506 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
Isomedix Operations, Inc. Registration: 2183744 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
SCT, INC. Registration: 2249615 View Registration
HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
STERIS SPA Registration: 3002806470 View Registration
STERIS SPA Registration: 3002806603 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3002807310 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
OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
MATERIALISE N.V. Registration: 3003998208 View Registration
Waldemar Link GmbH & Co. KG Registration: 3004371426 View Registration
ENZTEC LIMITED Registration: 3004641308 View Registration
SHANGHAI JPY ION-TECH CO., LTD. Registration: 3004748528 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
TURNER MEDICAL INC. Registration: 3005706667 View Registration
Materialise USA, LLC. Registration: 3005718816 View Registration
ADVANCED CONCEPT INNOVATIONS LLC Registration: 3006015326 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. Registration: 3006356043 View Registration
CANWELL MEDICAL CO., LTD. Registration: 3006395932 View Registration
Zhejiang Biomet Medical Products Co., Ltd. Registration: 3006801265 View Registration
SFERIC Registration: 3007200272 View Registration
MAXX ORTHOPEDICS INC. Registration: 3007311878 View Registration
Smith & Nephew, Inc. Registration: 3007366790 View Registration
Paragon Medical Device (Changzhou) Co., Ltd. Registration: 3007539489 View Registration
Changzhou Biomet Medical Devices Co., Ltd. Registration: 3007923096 View Registration
Limacorporate S.p.A. Registration: 3008021110 View Registration
Limacorporate S.p.A. Registration: 3008395353 View Registration
Exactech Sarasota Registration: 3008658204 View Registration
Smith & Nephew, Inc. Registration: 3008744062 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
TURNCO TOOL & INSTRUMENT, INC. Registration: 3009241418 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
ORCHID ORTHOPEDIC SOLUTIONS OREGON, INC. Registration: 3009848551 View Registration
PERRYMAN COMPANY Registration: 3009882462 View Registration
Orchid Orthopedic Solutions Alabama LLC Registration: 3009888740 View Registration
Engineered Medical Systems, LLC Registration: 3009973336 View Registration
ARCH Medical Solutions - Memphis Registration: 3009973505 View Registration
Lincotek Medical LLC Registration: 3010039400 View Registration
ALMARK TOOL & MANUFACTURING COMPANY, INC. Registration: 3010041693 View Registration
AUTOCAM MEDICAL Registration: 3010047402 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
Synergy Health Westport Ltd Registration: 3010173425 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
BGS Beta Gamma Service GmbH & Co KG Registration: 3010288357 View Registration
MICROPORT ORTHOPEDICS INC. Registration: 3010536692 View Registration
Advanced Machine, Inc. Registration: 3011061242 View Registration
WESTLAKE PLASTICS EUROPE Registration: 3011274144 View Registration
Suzhou Elite Precision Machinery Co., Ltd. Registration: 3011295718 View Registration
Zimmer Biomet Taiwan Co., Ltd. Registration: 3011683674 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
OEB S.R.L. Registration: 3013791180 View Registration
BIOMET CHILE S.A. Registration: 3014302784 View Registration
Suzhou Ahno Medical Devices Co., Ltd. Registration: 3014315669 View Registration
SUZHOU MICROPORT ORTHORECON CO., LTD. Registration: 3014662844 View Registration
Zimmer (Shanghai) Medical International Trading Co., Ltd. Registration: 3015207155 View Registration
Depuy Ireland UC Registration: 3015516266 View Registration
Zimmer Biomet Korea Ltd. Registration: 3015542154 View Registration
RESTORATION MEDICAL POLYMERS Registration: 3015916578 View Registration
Blue Belt Technologies, Inc. Registration: 3016090213 View Registration
ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
EDDI BRESSAN S.R.L. Registration: 3017397663 View Registration
MAKO SURGICAL CORP. Registration: 3017410889 View Registration
MACH MEDICAL Registration: 3020703621 View Registration
LINCOTEK MEDICAL, LLC Registration: 3020745236 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
STI LUALDI S.R.L. Registration: 3026771806 View Registration
VALTECNE SPA Registration: 3027484613 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 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
DEPUY INTL., LTD. Registration: 8010379 View Registration
Kammerer Medical Systems GmbH & Co. KG Registration: 8010916 View Registration
AESCULAP AG Registration: 9610612 View Registration
HOWMEDICA INTERNATIONAL S. DE R.L., Registration: 9610726 View Registration
Corin Limited Registration: 9614209 View Registration
DEPUY (IRELAND) Registration: 9616671 View Registration
STRYKER IRELAND OSTEONICS Registration: 9616680 View Registration
Gammatom S.r.l. Registration: 9681465 View Registration

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Medical Device Recall: Z-0009-2008

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer