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Zimmer, Inc.

971 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
REF 90-5970-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1601-2012)Zimmer Inc.2012-05-14
90-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1602-2012)Zimmer Inc.2012-05-14
REF 00-5972-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene recall (Z-1603-2012)Zimmer Inc.2012-05-14
00-5976-031-10, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1604-2012)Zimmer Inc.2012-05-14
00-5976-031-12, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1605-2012)Zimmer Inc.2012-05-14
00-5976-031-14, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1606-2012)Zimmer Inc.2012-05-14
00-5976-031-17, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1607-2012)Zimmer Inc.2012-05-14
00-5976-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1608-2012)Zimmer Inc.2012-05-14
00-5970-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1609-2012)Zimmer Inc.2012-05-14
00-5972-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1610-2012)Zimmer Inc.2012-05-14
00-5976-031-23, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruc recall (Z-1611-2012)Zimmer Inc.2012-05-14
Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zim recall (Z-1510-2012)Zimmer Inc.2012-05-10
Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.z recall (Z-1511-2012)Zimmer Inc.2012-05-10
Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmer recall (Z-1512-2012)Zimmer Inc.2012-05-10
Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R, www.zimmer recall (Z-1513-2012)Zimmer Inc.2012-05-10
Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX Rx recall (Z-1514-2012)Zimmer Inc.2012-05-10
Zimmer Dental Trabecular Metal Implant, TMM4B13, 4.1mm x13MM; 3.5 mm implant TM, MTX Rx, S recall (Z-1515-2012)Zimmer Inc.2012-05-10
Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul P recall (Z-0848-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm The Zimmer Natural-Knee II Durasul P recall (Z-0849-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm The Zimmer Natural-Knee II Durasul P recall (Z-0850-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm The Zimmer Natural-Knee II Durasul P recall (Z-0851-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm The Zimmer Natural-Knee II Durasul recall (Z-0852-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm The Zimmer Natural-Knee II Durasul recall (Z-0853-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm The Zimmer Natural-Knee II Durasul recall (Z-0854-2012)Zimmer Inc.2012-01-25
Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul recall (Z-0855-2012)Zimmer Inc.2012-01-25
5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitat recall (Z-0861-2012)Zimmer Inc.2012-01-25
Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices: Porous recall (Z-0321-2012)Zimmer Inc.2011-12-01
ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devi recall (Z-0322-2012)Zimmer Inc.2011-12-01
ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrite recall (Z-0323-2012)Zimmer Inc.2011-12-01
ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Po recall (Z-0324-2012)Zimmer Inc.2011-12-01
The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisti recall (Z-3279-2011)Zimmer Inc.2011-09-27
Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usag recall (Z-2722-2011)Zimmer Inc.2011-07-06
Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product Usa recall (Z-2723-2011)Zimmer Inc.2011-07-06
Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, recall (Z-2705-2011)Zimmer Inc.2011-06-29
NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF recall (Z-2173-2011)Zimmer Inc.2011-05-10
NEXGEN COMPLETE KNEE SOLUTION FEMORAL REPLACEMENT JAW FOR USE WITH FEMORAL AND PROVISIONAL recall (Z-2174-2011)Zimmer Inc.2011-05-10
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION, FEMORAL AND P recall (Z-1985-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFE recall (Z-1986-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION POSTERIOR REFE recall (Z-1987-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA PEG DR recall (Z-1988-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION QUICK-CONNECT recall (Z-1989-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION MODULAR T-HAND recall (Z-1990-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY recall (Z-1991-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY recall (Z-1992-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION EXTRAMEDULLARY recall (Z-1993-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL recall (Z-1994-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION FEMORAL VALGUS recall (Z-1995-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA CLAMP, recall (Z-1996-2011)Zimmer Inc.2011-04-14
Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA OSTEOT recall (Z-1997-2011)Zimmer Inc.2011-04-14
TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, War recall (Z-0887-2011)Zimmer Inc.2011-01-10
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-5 recall (Z-0824-2011)Zimmer Inc.2010-12-28
Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-05 recall (Z-0619-2011)Zimmer Inc.2010-12-14
NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zi recall (Z-0609-2011)Zimmer Inc.2010-12-13
NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-588 recall (Z-0610-2011)Zimmer Inc.2010-12-13
Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, R recall (Z-0602-2011)Zimmer Inc.2010-12-10
Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 7 recall (Z-0603-2011)Zimmer Inc.2010-12-10
Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX, REF recall (Z-0604-2011)Zimmer Inc.2010-12-10
Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, T recall (Z-0605-2011)Zimmer Inc.2010-12-10
ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of th recall (Z-0570-2011)Zimmer Inc.2010-12-09
ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of t recall (Z-0571-2011)Zimmer Inc.2010-12-09
BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation recall (Z-0572-2011)Zimmer Inc.2010-12-09
TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Meta recall (Z-0573-2011)Zimmer Inc.2010-12-09
Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, R recall (Z-0574-2011)Zimmer Inc.2010-12-09
Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97 recall (Z-0575-2011)Zimmer Inc.2010-12-09
Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309 recall (Z-0576-2011)Zimmer Inc.2010-12-09
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00- recall (Z-0528-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00 recall (Z-0529-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00- recall (Z-0530-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00 recall (Z-0531-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00 recall (Z-0532-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, ster recall (Z-0533-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, ste recall (Z-0534-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, ster recall (Z-0535-2011)Zimmer Inc.2010-12-02
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, ste recall (Z-0536-2011)Zimmer Inc.2010-12-02
Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Z recall (Z-0493-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, recall (Z-0494-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-0 recall (Z-0495-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-117 recall (Z-0496-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer Inc. recall (Z-0497-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer I recall (Z-0498-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Offset Clamp Tips Inline, Item # 00-1179-028-01, Zimmer Inc., recall (Z-0499-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset, Item # 00-1179-028-02, Zimme recall (Z-0500-2011)Zimmer Inc.2010-12-01
Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item # 00-1179-028-03, Zimme recall (Z-0501-2011)Zimmer Inc.2010-12-01
Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants. recall (Z-0444-2011)Zimmer Inc.2010-11-23
NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, recall (Z-0119-2011)Zimmer Inc.2010-10-21
NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 3, REF 00-5980-037-01, recall (Z-0120-2011)Zimmer Inc.2010-10-21
Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbot recall (Z-0075-2011)Zimmer Inc.2010-10-18
Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-0 recall (Z-0071-2011)Zimmer Inc.2010-10-15
Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-00 recall (Z-0072-2011)Zimmer Inc.2010-10-15
Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, C recall (Z-0060-2011)Zimmer Inc.2010-10-14
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S recall (Z-0026-2011)Zimmer Inc.2010-10-08
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M recall (Z-0027-2011)Zimmer Inc.2010-10-08
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L recall (Z-0028-2011)Zimmer Inc.2010-10-08
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL recall (Z-0029-2011)Zimmer Inc.2010-10-08
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S recall (Z-0030-2011)Zimmer Inc.2010-10-08
SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M recall (Z-0031-2011)Zimmer Inc.2010-10-08
SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L recall (Z-0032-2011)Zimmer Inc.2010-10-08
SpeedLink 6.0 Transverse Connector X-Long 60-75mm, non-sterile, 1304-60XL recall (Z-0033-2011)Zimmer Inc.2010-10-08
TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective o recall (Z-2439-2010)Zimmer Inc.2010-09-20
TRABECULAR METAL FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32. The objective recall (Z-2440-2010)Zimmer Inc.2010-09-20
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Every clearance here is in the API, with alerts when new ones post.