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Zimmer, Inc.

971 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. recall (Z-1014-2014)Zimmer, Inc.2014-02-20
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL D recall (Z-1015-2014)Zimmer, Inc.2014-02-20
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON recall (Z-1016-2014)Zimmer, Inc.2014-02-20
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON recall (Z-1017-2014)Zimmer, Inc.2014-02-20
MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001 recall (Z-1018-2014)Zimmer, Inc.2014-02-20
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42 recall (Z-1019-2014)Zimmer, Inc.2014-02-20
NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500 recall (Z-1020-2014)Zimmer, Inc.2014-02-20
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 a recall (Z-1021-2014)Zimmer, Inc.2014-02-20
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POL recall (Z-1022-2014)Zimmer, Inc.2014-02-20
MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP recall (Z-1023-2014)Zimmer, Inc.2014-02-20
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET recall (Z-1024-2014)Zimmer, Inc.2014-02-20
HGP II ACETABULAR CUP BON recall (Z-1025-2014)Zimmer, Inc.2014-02-20
HGP II ACETABULAR CUP MOD recall (Z-1026-2014)Zimmer, Inc.2014-02-20
PRESSFIT FEM ST FX 16 X 1 recall (Z-1027-2014)Zimmer, Inc.2014-02-20
VERSYS HERITAGE FEM STEM recall (Z-1028-2014)Zimmer, Inc.2014-02-20
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM L recall (Z-1029-2014)Zimmer, Inc.2014-02-20
ZIMTRON 6 DEG 22 HEADS recall (Z-1030-2014)Zimmer, Inc.2014-02-20
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) recall (Z-1031-2014)Zimmer, Inc.2014-02-20
CPT 12/14 COCR (various sizes) recall (Z-1032-2014)Zimmer, Inc.2014-02-20
6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE recall (Z-1033-2014)Zimmer, Inc.2014-02-20
6 DEGREE COCR FEM HEAD 36 recall (Z-1034-2014)Zimmer, Inc.2014-02-20
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID recall (Z-1035-2014)Zimmer, Inc.2014-02-20
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) recall (Z-1036-2014)Zimmer, Inc.2014-02-20
FEM HD ION (various sizes) recall (Z-1037-2014)Zimmer, Inc.2014-02-20
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S recall (Z-1038-2014)Zimmer, Inc.2014-02-20
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) recall (Z-1039-2014)Zimmer, Inc.2014-02-20
PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM recall (Z-1040-2014)Zimmer, Inc.2014-02-20
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT recall (Z-1041-2014)Zimmer, Inc.2014-02-20
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 COR recall (Z-1042-2014)Zimmer, Inc.2014-02-20
3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 CO recall (Z-1043-2014)Zimmer, Inc.2014-02-20
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 COR recall (Z-1044-2014)Zimmer, Inc.2014-02-20
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bo recall (Z-0783-2014)Zimmer, Inc.2014-01-17
Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement. recall (Z-0784-2014)Zimmer, Inc.2014-01-17
Palacos R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acryl recall (Z-0730-2014)Zimmer, Inc.2014-01-13
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-const recall (Z-0608-2014)Zimmer, Inc.2013-12-30
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder sy recall (Z-0609-2014)Zimmer, Inc.2013-12-30
Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in recall (Z-0610-2014)Zimmer, Inc.2013-12-30
FEM COND BUTTRESS PLT, RT. recall (Z-0585-2014)Zimmer, Inc.2013-12-27
TIBIO FEM/FEM NAIL. recall (Z-0586-2014)Zimmer, Inc.2013-12-27
DIST LAT FEM LOCK PLT, LT recall (Z-0587-2014)Zimmer, Inc.2013-12-27
DIST LAT FEM LOCK PLT, RT recall (Z-0588-2014)Zimmer, Inc.2013-12-27
ITST THREADED GUIDE PIN recall (Z-0589-2014)Zimmer, Inc.2013-12-27
NGK Stem Ext 24 x 245mm recall (Z-0590-2014)Zimmer, Inc.2013-12-27
FEM COND BUTTRESS PLT, LT recall (Z-0591-2014)Zimmer, Inc.2013-12-27
TIB NAIL recall (Z-0592-2014)Zimmer, Inc.2013-12-27
NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates a recall (Z-0480-2014)Zimmer, Inc.2013-12-11
Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplast recall (Z-0475-2014)Zimmer, Inc.2013-12-10
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplas recall (Z-0476-2014)Zimmer, Inc.2013-12-10
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplas recall (Z-0477-2014)Zimmer, Inc.2013-12-10
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non ster recall (Z-0459-2014)Zimmer, Inc.2013-12-06
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non ster recall (Z-0460-2014)Zimmer, Inc.2013-12-06
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsteril recall (Z-0461-2014)Zimmer, Inc.2013-12-06
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsteril recall (Z-0462-2014)Zimmer, Inc.2013-12-06
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height No recall (Z-0463-2014)Zimmer, Inc.2013-12-06
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The T recall (Z-0357-2014)Zimmer, Inc.2013-11-18
VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System recall (Z-0277-2014)Zimmer, Inc.2013-11-14
Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/p recall (Z-0129-2014)Zimmer, Inc.2013-11-01
Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture disloc recall (Z-0068-2014)Zimmer, Inc.2013-10-25
CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SI recall (Z-0069-2014)Zimmer, Inc.2013-10-25
Versys Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200M recall (Z-0070-2014)Zimmer, Inc.2013-10-25
Metasul Head. Intended for use either with or without bone cement in total hip arthroplast recall (Z-0071-2014)Zimmer, Inc.2013-10-25
CoCr Head (Not distributed in the United States) Used in total hip replacement. recall (Z-0072-2014)Zimmer, Inc.2013-10-25
NexGen Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX recall (Z-0073-2014)Zimmer, Inc.2013-10-25
NexGen Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF recall (Z-0074-2014)Zimmer, Inc.2013-10-25
Natural-Knee Flex Femoral Component. Provides increased flexion capability. recall (Z-0075-2014)Zimmer, Inc.2013-10-25
Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or recall (Z-0076-2014)Zimmer, Inc.2013-10-25
Gender Solutions" Patello-Femoral Component recall (Z-0077-2014)Zimmer, Inc.2013-10-25
Natural-Knee II Femoral Component recall (Z-0078-2014)Zimmer, Inc.2013-10-25
Sidus" Head (Not distributed in the United States) recall (Z-0079-2014)Zimmer, Inc.2013-10-25
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) recall (Z-0080-2014)Zimmer, Inc.2013-10-25
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT recall (Z-2101-2013)Zimmer, Inc.2013-08-27
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (s recall (Z-2055-2013)Zimmer, Inc.2013-08-26
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 m recall (Z-2090-2013)Zimmer, Inc.2013-08-26
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91 recall (Z-2091-2013)Zimmer, Inc.2013-08-26
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), recall (Z-2092-2013)Zimmer, Inc.2013-08-26
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profile recall (Z-2093-2013)Zimmer, Inc.2013-08-26
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profi recall (Z-2094-2013)Zimmer, Inc.2013-08-26
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT recall (Z-1998-2013)Zimmer, Inc.2013-08-22
00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SU recall (Z-1999-2013)Zimmer, Inc.2013-08-22
00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM recall (Z-2000-2013)Zimmer, Inc.2013-08-22
65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM recall (Z-2001-2013)Zimmer, Inc.2013-08-22
00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SUR recall (Z-2002-2013)Zimmer, Inc.2013-08-22
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATC recall (Z-2003-2013)Zimmer, Inc.2013-08-22
00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT recall (Z-2004-2013)Zimmer, Inc.2013-08-22
00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx recall (Z-2005-2013)Zimmer, Inc.2013-08-22
00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R R recall (Z-2006-2013)Zimmer, Inc.2013-08-22
00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R R recall (Z-2007-2013)Zimmer, Inc.2013-08-22
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HAT recall (Z-2008-2013)Zimmer, Inc.2013-08-22
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP recall (Z-2009-2013)Zimmer, Inc.2013-08-22
00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SUR recall (Z-2010-2013)Zimmer, Inc.2013-08-22
00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SI recall (Z-2011-2013)Zimmer, Inc.2013-08-22
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SU recall (Z-2012-2013)Zimmer, Inc.2013-08-22
65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM recall (Z-2013-2013)Zimmer, Inc.2013-08-22
00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO P recall (Z-2014-2013)Zimmer, Inc.2013-08-22
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL PO recall (Z-2015-2013)Zimmer, Inc.2013-08-22
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articu recall (Z-2016-2013)Zimmer, Inc.2013-08-22
90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Artic recall (Z-2017-2013)Zimmer, Inc.2013-08-22
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular recall (Z-2018-2013)Zimmer, Inc.2013-08-22
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articul recall (Z-2019-2013)Zimmer, Inc.2013-08-22
00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular recall (Z-2020-2013)Zimmer, Inc.2013-08-22
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