FDA Device Recall Z-0044-2011: Smith & Nephew, Inc. Endoscopy Division

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2011.

Recall Res Number

Z-0044-2011

Recalling Firm / Manufacturer

Smith & Nephew, Inc. Endoscopy Division

FEI Number

3003604053

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-04-29

Date Posted

2010-10-12

Date Terminated

2012-05-09

Product Code

NBH

Event Number

55602

Product Quantity

704 units

Product Description Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Reason for Recall Endofemoral Aimer tip may separate due to failure of the soldered joint

Action Details Smith & Nephew sent a "Medical Device Recall Information" letter dated April 29, 2010, with an attached "Urgent-Product Recall 1st Notification - Urgent" response form via Federal Express on April 29, 2010, to all customers. An e-mail was sent to the contacts in the identified OUS countries alerting them of the recall. ( Note: On June 24, 2010, the firm expanded the recall to include 4 additional catalog numbers 7220l713F, 72201714F, 72201715F, 722017l6F that are refurbished and one additional lot number to catalog Number: 72201714.) The letter described the product, problem and action to be taken by customers. The customers were instructed to immediately check stock for affected product; immediately remove the items from stock and set aside for quarantine; complete and return the attached Urgent-Product Recall 1st Notification - Urgent" response form, even if no product is being returned, via fax at +1-508-261-3636 attention Cindy Burns or email a PDF to Cindy.Burns@smith-nephew.com; call for a return Authorization number at 1-800-343-5717 Option #3, and return product to Smith & Nephew, Inc., Endoscopy Division as soon as possible. If you have any questions or require additional information, please contact Cindy Burns at 1-508-261-3655.

Distribution Pattern Worldwide distribution: USA and countries including: Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Denmark. Dubal, Finland, France. Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Netherlands. Norway, Portugal, Puer To Rico, Singapore. South Africa, Spain. Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.

Code Information / Serial Numbers Lot Numbers: 50257076, 50270510, 50275315, 50291511, 50303479, 50278015, 502780151, 50294881

Related Establishments / Registrations

TRIANGLE MANUFACTURING CO., INC. Registration: 1000491390 View Registration
Paragon Medical Inc. Registration: 1000517406 View Registration
Linvatec Corporation Registration: 1017294 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 1030489 View Registration
SUNOPTIC TECHNOLOGIES, LLC Registration: 1035968 View Registration
Sterigenics U.S., LLC Registration: 1036836 View Registration
ONYX MEDICAL LLC Registration: 1043653 View Registration
MEDTRONIC XOMED, INC. Registration: 1045254 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
INTERNATIONAL STERILIZATION LABORATORY, LLC Registration: 1061927 View Registration
AME INT'L. Registration: 1064017 View Registration
Cadence Science, Inc. Registration: 1213649 View Registration
SMITH & NEPHEW INC. Registration: 1219602 View Registration
ARTHREX, INC. Registration: 1220246 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
DePuy Mitek, Inc. Registration: 1221934 View Registration
GEOTEC, INC. Registration: 1222773 View Registration
Primo Medical Group, INC Registration: 1222928 View Registration
LAB Medical Manufacturing, Inc. Registration: 1223421 View Registration
Vericel Corporation Registration: 1226230 View Registration
MILLSTONE MEDICAL OUTSOURCING LLC. Registration: 1226544 View Registration
ELMED, INC. Registration: 1412854 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
RICHARD WOLF MEDICAL INSTRUMENTS CORP. Registration: 1418479 View Registration
Instrumed International Inc dba Avalign German Specialty Instruments Registration: 1421101 View Registration
PHOENIX INSTRUMENTS, INC. Registration: 1421879 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
FRANTZ MEDICAL DEVELOPMENT, LTD. Registration: 1526605 View Registration
ISOMEDIX OPERATIONS INC Registration: 1526711 View Registration
Criterion Tool & Die Inc DBA Criterion Precision Machining Registration: 1528668 View Registration
SMITH & NEPHEW INC. Registration: 1643264 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
Steritec Services, LLC Registration: 1647149 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
ZIMMER, INC. Registration: 1822565 View Registration
WARSAW ORTHOPEDIC, INC. Registration: 1824199 View Registration
FORT WAYNE METALS RESEARCH PRODUCTS, LLC Registration: 1824313 View Registration
BIOMET, INC. Registration: 1825034 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
SYMMETRY MEDICAL MANUFACTURING INC. Registration: 1828464 View Registration
INNOMED, INC. Registration: 1833053 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
INSTRUMENTAL MACHINE & DEVELOPMENT, INC. Registration: 1835998 View Registration
C+A TOOL ENGINEERING, INC. Registration: 1836357 View Registration
SURGICAL INSTRUMENT MANUFACTURERS, LLC Registration: 1935627 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
MICROAIRE SURGICAL INSTRUMENTS LLC Registration: 2020601 View Registration
ARMM, INC. Registration: 2028523 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
LIFE SCIENCE OUTSOURCING, INC. Registration: 2031093 View Registration
CLASSIC WIRE CUT COMPANY, INC. Registration: 2031917 View Registration
NUVASIVE, INC. Registration: 2031966 View Registration
SPECIALTEAM Registration: 2032092 View Registration
INSIGHTRA MEDICAL, INC. Registration: 2032677 View Registration
ORTHOPEDIC SCIENCES, INC Registration: 2032830 View Registration
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. Registration: 2085947 View Registration
Lake Region Medical Registration: 2126666 View Registration
TECOMET, INC. Registration: 2132732 View Registration
Metal Craft Machine & Engineering, Inc. Registration: 2133928 View Registration
RIVERSIDE MACHINE & ENGINEERING, INC. Registration: 2134285 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
PHOENIX MEDICAL PRODUCTS, INC. Registration: 2320767 View Registration
Sklar Corporation Registration: 2431166 View Registration
A.M. SURGICAL, INC. Registration: 2437731 View Registration
C & J INDUSTRIES, INC. Registration: 2522206 View Registration
MED SAVER, INC. Registration: 2529846 View Registration
MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO Registration: 2647346 View Registration
STERIS ISOMEDIX PUERTO RICO, INC. Registration: 2648623 View Registration
Baxter Healthcare of Puerto Rico LLC Registration: 2649614 View Registration
AESCULAP, INC. Registration: 2916714 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
Sterigenics U.S. LLC Registration: 2953359 View Registration
3D MEDICAL MANUFACTURING, INC. (dba Tecomet) Registration: 3001239363 View Registration
Arthrex GmbH Registration: 3002579136 View Registration
Wenzler Medizintechnik GmbH Registration: 3002862271 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
MEDTRONIC SOFAMOR DANEK USA, INC. Registration: 3003120897 View Registration
CELESTICA de MONTERREY S.A. de C.V. Registration: 3003139373 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
MIDWEST PRODUCTS AND ENGINEERING Registration: 3003500271 View Registration
SMITH & NEPHEW INC. Registration: 3003604053 View Registration
FARMACO QUIMICA NACIONAL, S.A. Registration: 3003755939 View Registration
MACKAY MANUFACTURING, INC. Registration: 3003935342 View Registration
BESTER MEDICAL SYSTEM SP. Z O. O. Registration: 3003973936 View Registration
MILLENNIUM SURGICAL CORP Registration: 3004215117 View Registration
HURON TOOL & CUTTER GRINDING Registration: 3004358587 View Registration
AMERICAN MEDICAL ENDOSCOPY Registration: 3004361445 View Registration
DEPUY ORTHOPAEDICS Registration: 3004464325 View Registration
SUMMIT MFG. AND MACHINING, INC. Registration: 3004504812 View Registration
CANNUFLOW, INC. Registration: 3004957622 View Registration
SYMMETRY MEDICAL MANUFACTURING INC Registration: 3005061536 View Registration
JOIMAX GMBH Registration: 3005083075 View Registration
MEDACTA INTERNATIONAL SA Registration: 3005180920 View Registration
SURETEK MEDICAL Registration: 3005575604 View Registration
PACIFIC INSTRUMENTS INC. Registration: 3005641619 View Registration
Medtronic (Changzhou) Medical Devices Technology Co., Ltd Registration: 3005677016 View Registration
ARCH-MedTorque Registration: 3005874553 View Registration
CAYENNE MEDICAL, INC. Registration: 3006108336 View Registration
Nemcomed FW LLC Registration: 3006128100 View Registration
SMC Medical Manufacturing Private Limited Registration: 3006467300 View Registration
INNOMED, S.A. DE C.V. Registration: 3006498370 View Registration
ArthroCare Corporation Registration: 3006524618 View Registration
KARL STORZ SE & CO. KG Registration: 3006546082 View Registration
Hoogland Spine Products GmbH Registration: 3006561161 View Registration
ETHICON, INC. Registration: 3006638824 View Registration
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD Registration: 3006639944 View Registration
Bradshaw Medical Inc. Registration: 3006846753 View Registration
Arthrex California Technology, Incorporated Registration: 3006990600 View Registration
Apex (Guangzhou) Tools & Orthopedics Company Registration: 3007125392 View Registration
ARTHREX GMBH Registration: 3007193505 View Registration
Consolidated Medical Equipment Company Registration: 3007305485 View Registration
PARCUS MEDICAL , L.L.C. Registration: 3007319107 View Registration
MOSER-BAER AG Registration: 3007441485 View Registration
Synergy Health AST, SRL Registration: 3007738736 View Registration
MEDACTA INTERNATIONAL SA Registration: 3008110533 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
CURRIER MOS PLASTICS LLC Registration: 3008513917 View Registration
TRIDENT MANUFACTURING, INC. Registration: 3008717566 View Registration
NOVO SURGICAL, INC. Registration: 3008770252 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
EXEL INC. DBA DHL SUPPLY CHAIN (USA) Registration: 3008868758 View Registration
GETSCH + HILLER MEDIZINTECHNIK GMBH Registration: 3008911114 View Registration
CORENTEC CO., LTD. Registration: 3009106092 View Registration
AMETEK Poland sp. z o.o. Registration: 3009141957 View Registration
NUVASIVE, INC. Registration: 3009144915 View Registration
PT. TRANSMEDIC INDONESIA Registration: 3009251316 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
LEITNER AG Registration: 3009381600 View Registration
SYNTHES GMBH Registration: 3009417901 View Registration
Spinendos GmbH Registration: 3009499159 View Registration
HNM Medical dba HNM TOTAL RECON Registration: 3009513193 View Registration
NEXUS CMF Registration: 3009702671 View Registration
BGS BETA-GAMMA-SERVICE GMBH & CO KG Registration: 3009732568 View Registration
ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 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
PRECISION IDENTITY CORP. / KAMBER Registration: 3009974364 View Registration
BIORAD MEDISYS PVT. LTD. Registration: 3010011359 View Registration
Apollo Renal Therapeutics, LLC Registration: 3010032115 View Registration
Lincotek Medical LLC Registration: 3010039400 View Registration
AUTOCAM MEDICAL Registration: 3010047402 View Registration
LS INVESTMENT II Registration: 3010128826 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
Auxein medical Private limited Registration: 3010303097 View Registration
Arthrex, Inc. Registration: 3010331645 View Registration
INVIDIA MEDICAL GMBH U CO KG Registration: 3010399422 View Registration
TRIBE MEDICAL GROUP Registration: 3010400367 View Registration
JIGSAW MEDICAL, LLC Registration: 3010546717 View Registration
CADENCE DEVICE, INC. Registration: 3010659131 View Registration
Surgical Specialties Mexico S DE RL DE CV Registration: 3010692967 View Registration
KARL STORZ SE & CO. KG Registration: 3010707607 View Registration
TECHNICAL MANUFACTURING WEST, LLC Registration: 3011070496 View Registration
Arthrex Mexico, S.A. de C.V. Registration: 3011230048 View Registration
AUTHORIZED ACQUISITIONS LLC Registration: 3011277660 View Registration
Suzhou Elite Precision Machinery Co., Ltd. Registration: 3011295718 View Registration
Lincotek Medical LLC Registration: 3011299238 View Registration
SANTA BARBARA IMAGING SYSTEMS Registration: 3011373951 View Registration
INTEGRATED ENDOSCOPY, INC. Registration: 3011401113 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
SURGIPROS LLC Registration: 3012267976 View Registration
KARL STORZ ENDOSCOPY CANADA LTD. Registration: 3012322232 View Registration
ORTOSISTEMAS, S.A. Registration: 3012329552 View Registration
Arthrocare Corporation Registration: 3012358417 View Registration
Arthrex Japan G.K. (Shinjuku) Registration: 3012470322 View Registration
SANICURE BV Registration: 3012494290 View Registration
Device Innovation Company Limited Registration: 3012818475 View Registration
CROSMED S.A. Registration: 3012883081 View Registration
MAHE MEDICAL USA Registration: 3013011598 View Registration
MECTALENT LTD. Registration: 3013156185 View Registration
ARVATO Netherlands B.V. Registration: 3013302242 View Registration
Viant San Antonio, Inc. Registration: 3013404959 View Registration
Teufel & Gerlach GmbH Registration: 3013497507 View Registration
Arthrex Korea Ltd. Registration: 3013700547 View Registration
GM DOS REIS INDUSTRIA E COMERCIO LTDA Registration: 3013756169 View Registration
Anhui Shiyin Photoelectric Instrument Co., Ltd. Registration: 3013831261 View Registration
GREENS SURGICALS PRIVATE LIMITED Registration: 3013846070 View Registration
Arthrex Singapore Pte Ltd. Registration: 3014004349 View Registration
RENOVO, INC. Registration: 3014023545 View Registration
UTITEC MEDICAL S.A. Registration: 3014032451 View Registration
Ascension Orthopedics, Inc. Registration: 3014207283 View Registration
Arthrex (Shanghai) Co., Ltd. Registration: 3014262693 View Registration
Suzhou Ahno Medical Devices Co., Ltd. Registration: 3014315669 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
Microtek Medical LLC Registration: 3014342658 View Registration
AMNOTEC INTERNATIONAL MEDICAL GMBH Registration: 3014615697 View Registration
Domico Med-Device, LLC Registration: 3014680784 View Registration
Medtronic Medical Costa Rica S.R.L. Registration: 3014725904 View Registration
B-ONE MEDICAL (SUZHOU) CO., LTD. Registration: 3015167917 View Registration
Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration
Arthrex Manufacturing Inc. Registration: 3015231789 View Registration
B-ONE ORTHO, CORP. Registration: 3015259876 View Registration
VOLMED BRASIL EQUIPAMENTOS LTDA Registration: 3015330458 View Registration
Jabil Inc. (Monument) Registration: 3015399803 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
JOINSMART BIOMEDICAL CO., LTD. Registration: 3015539532 View Registration
I-MEDICAL ASIA COMPANY LIMITED Registration: 3015806723 View Registration
Jabil Switzerland Manufacturing GmbH (Le Locle) Registration: 3015831087 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
HEINRICH MEDIZINTECHNIK GMBH Registration: 3015972835 View Registration
Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda Registration: 3015974593 View Registration
ARCH Medical Solutions - Memphis Registration: 3016438694 View Registration
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED Registration: 3016443334 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY Registration: 3016727307 View Registration
Arthrex Distribution Hub EMEA B.V. Registration: 3016851379 View Registration
TIANCK MEDICAL CO.,LTD Registration: 3016950436 View Registration
BRDH Registration: 3017196117 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
ARTFX MEDICAL LLC Registration: 3017435639 View Registration
NANICE MEDICAL SOLUTIONS, LLC Registration: 3017450165 View Registration
ZHONGSHAN SAXIN ELECTRIC HEATING TECHNOLOGY CO., LTD. Registration: 3017607477 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Arthrex Australia Pty Ltd. Registration: 3019269298 View Registration
PRISTINE SURGICAL LLC Registration: 3019766696 View Registration
Transmedic Philippines Inc. Registration: 3020899789 View Registration
ARVATO USA LLC Registration: 3021008900 View Registration
Arthrex Colombia SAS Registration: 3021226419 View Registration
BIOCELLS DISCOVERIES INTERNACIONAL (BIOCELLS) Registration: 3021336182 View Registration
BIOGENOMICS S.A.C. - BIOCELLS SURGICAL Registration: 3021393544 View Registration
GREEN OR LLC Registration: 3021477808 View Registration
RAZEK EQUIPAMENTOS LTDA Registration: 3021907852 View Registration
Microtek Medical LLC Registration: 3021970868 View Registration
MAXMORESPINE Registration: 3023155873 View Registration
INKA SURGICAL INSTRUMENTS Registration: 3023657851 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
MDTGLOBAL, A.S. Registration: 3024021261 View Registration
ORTHO-DESIGN Registration: 3024856795 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3025603301 View Registration
QINGDAO ZHIXING MEDICAL INSTRUMENT CO., LTD. Registration: 3026133770 View Registration
BIOTEC BIOTECNOLOGIAS DE CENTROAMERICA S.A. Registration: 3027242374 View Registration
Arthrex Chile SPA Registration: 3027339877 View Registration
UTESHIYA MEDICARE PRIVATE LIMITED Registration: 3030188041 View Registration
SUZHOU ENDOPHIX CO., LTD. Registration: 3030514683 View Registration
ANQING CHANGFAN MEDICAL INSTRUMENT CO., LTD Registration: 3030535035 View Registration
MEDCARE SOLUTIONS GMBH Registration: 3031240334 View Registration
Medline ReNewal Registration: 3032391 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3033509898 View Registration
MATTES INSTRUMENTE GMBH Registration: 3035678069 View Registration
MED2B LTD. Registration: 3035708926 View Registration
STRAITS ORTHOPAEDICS (MFG) SDN BHD Registration: 3036756245 View Registration
JIANGXI VISION PLUS MEDICAL TECHNOLOGY CO.,LTD Registration: 3038191237 View Registration
Smith & Nephew, Inc. Registration: 3038503932 View Registration
HYDRUMEDICAL, S.A. Registration: 3039017337 View Registration
b-ONE Ortho Corp. Registration: 3042508254 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
CENTRAL ACCESS SOLUTIONS LLC Registration: 3043236407 View Registration
ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA Registration: 3043620689 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
HERMANN MEDIZINTECHNIK GMBH Registration: 8010257 View Registration
ACKERMANN INSTRUMENTE GMBH Registration: 8010273 View Registration
RUDOLF MEDICAL GMBH + CO. KG Registration: 8010298 View Registration
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG Registration: 8010349 View Registration
Instrumed GmbH dba Avalign German Specialty Instruments Registration: 8010372 View Registration
HENKE-SASS WOLF, GMBH. Registration: 8010418 View Registration
GEISTER MEDIZINTECHNIK GMBH Registration: 8010697 View Registration
STRYKER GmbH Registration: 8031020 View Registration
Falcon Surgical Co. (Pvt.) Ltd. Registration: 8040278 View Registration
BAK KOHLER Medical KG Registration: 8043548 View Registration
TROKAMED GMBH Registration: 8043746 View Registration
MICROTEK DOMINICANA, S.A.S. Registration: 8043817 View Registration
T.A.G. MEDICAL PRODUCTS CORPORATION LTD Registration: 8043971 View Registration
Vitalitec International Medizintechnik GmbH Registration: 8044057 View Registration
HGR INSTRUMENTE GMBH Registration: 8044098 View Registration
AESCULAP AG Registration: 9610612 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
RICHARD WOLF GMBH Registration: 9611102 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
Stengelin Medical GmbH Registration: 9611278 View Registration
DIMEDA INSTRUMENTE GMBH Registration: 9611283 View Registration
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH Registration: 9611503 View Registration
ILG MEDIZINTECHNIK GMBH Registration: 9611610 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
JAKUTEC MEDIZINTECHNIK GMBH & Co. KG Registration: 9612277 View Registration
Gesco Healthcare Private Limited Registration: 9613926 View Registration
EFINGER INSTRUMENTS GmbH & Co. KG Registration: 9615004 View Registration
J. STERLING INDUSTRIES LTD. Registration: 9615896 View Registration
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. Registration: 9616086 View Registration
PFAU MEDIZINISCHE INSTRUMENTE GMBH Registration: 9617426 View Registration
TONTARRA MEDIZINTECHNIK GMBH Registration: 9680515 View Registration
RZ MEDIZINTECHNIK GMBH Registration: 9680718 View Registration
BLAZEJEWSKI MEDI-TECH GMBH Registration: 9710457 View Registration
INION OY Registration: 9710629 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-0044-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer