Zimmer GmbH
Warsaw, IN, US
ZIMMER GMBH appears in FDA device records in Warsaw, IN. FDA records list 872 510(k) clearances between and , 152 PMA records and 5 registered establishments. As of , FDA records show 2,495 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Zimmer GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Biomet, Inc.registration, 510(k), PMA, enforcement report, recall
- Zimmer Biomet Pty Ltdregistration, 510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 872FDA records hold 872 510(k) clearances for Zimmer GmbH between 1976 and 2026. The busiest year on record is 2005, with 43. The most recent is 2026, with 10.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 1 |
| 1978 | 18 |
| 1979 | 9 |
| 1980 | 12 |
| 1981 | 17 |
| 1982 | 7 |
| 1983 | 18 |
| 1984 | 11 |
| 1985 | 10 |
| 1986 | 8 |
| 1987 | 8 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 8 |
| 1991 | 14 |
| 1992 | 15 |
| 1993 | 9 |
| 1994 | 28 |
| 1995 | 22 |
| 1996 | 29 |
| 1997 | 21 |
| 1998 | 28 |
| 1999 | 39 |
| 2000 | 40 |
| 2001 | 34 |
| 2002 | 28 |
| 2003 | 35 |
| 2004 | 36 |
| 2005 | 43 |
| 2006 | 20 |
| 2007 | 19 |
| 2008 | 16 |
| 2009 | 12 |
| 2010 | 13 |
| 2011 | 13 |
| 2012 | 18 |
| 2013 | 22 |
| 2014 | 32 |
| 2015 | 28 |
| 2016 | 13 |
| 2017 | 10 |
| 2018 | 11 |
| 2019 | 24 |
| 2020 | 20 |
| 2021 | 5 |
| 2022 | 8 |
| 2023 | 2 |
| 2024 | 8 |
| 2025 | 9 |
| 2026 | 10 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | JDI | Substantially Equivalent | |
| K261683 | Augment Off-Axis Instrument System | PHX | Substantially Equivalent | |
| K260831 | Z1 Hip System | LZO | Substantially Equivalent | |
| K251840 | Zimmer® Persona® Personalized Knee System | MBH | Substantially Equivalent | |
| K251270 | Taperloc® Complete Hip Stem | LPH | Substantially Equivalent | |
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | LZO | Substantially Equivalent | |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | MBF | Substantially Equivalent | |
| K253566 | Affixus Retrograde Femoral Nailing System | HSB | Substantially Equivalent | |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | MBH | Substantially Equivalent | |
| K252623 | G7® Revision Acetabular System | LPH | Substantially Equivalent | |
| K251834 | Persona Partial Knee | HSX | Substantially Equivalent | |
| K251098 | Identity Revision Humeral Stems | MBF | Substantially Equivalent | |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | JDI | Substantially Equivalent | |
| K251620 | A.L.P.S. Proximal Humerus Plating System | HRS | Substantially Equivalent | |
| K251906 | Z1 Hip System | LZO | Substantially Equivalent | |
| K250848 | Identity Shoulder System | MBF | Substantially Equivalent | |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | LZO | Substantially Equivalent | |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | JWH | Substantially Equivalent | |
| K243907 | Affixus Tibial Nailing System - 4mm screws | HSB | Substantially Equivalent | |
| K243293 | Zimmer® Persona® Personalized Knee System | MBH | Substantially Equivalent | |
| K241873 | OsseoFit Stemless Shoulder System | PKC | Substantially Equivalent | |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | MBH | Substantially Equivalent | |
| K243247 | Persona the Personalized Knee System | MBH | Substantially Equivalent | |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | HSB | Substantially Equivalent | |
| K240876 | Identity Shoulder System | MBF | Substantially Equivalent | |
| K241014 | Biomet Kirschner Wires (K-Wires) | HTY | Substantially Equivalent | |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | MBH | Substantially Equivalent | |
| K230321 | Persona™ Personalized Knee System | JWH | Substantially Equivalent | |
| K211047 | CoCr Head | LPH | Substantially Equivalent | |
| K222760 | StageOne™ Select Hip Cement Spacer Molds | MBB | Substantially Equivalent | |
| K221479 | Persona Personalized Knee System | JWH | Substantially Equivalent | |
| K222566 | Zimmer Persona Personalized Knee System | MBH | Substantially Equivalent | |
| K221968 | StageOne™ Shoulder Cement Spacer Molds | MBB | Substantially Equivalent | |
| K213856 | Identity Shoulder System | MBF | Substantially Equivalent | |
| K213287 | StageOne Knee Cement Spacer Molds | MBB | Substantially Equivalent | |
| K212512 | G7® Vivacit-E® Freedom® Constrained Liner | PBI | Substantially Equivalent | |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | JDG | Substantially Equivalent | |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | KWS | Substantially Equivalent | |
| K210842 | VerSys Cemented Revision/Calcar | JDI | Substantially Equivalent | |
| K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | JWH | Substantially Equivalent | |
| K210551 | Persona Revision Knee System | JWH | Substantially Equivalent | |
| K210192 | A.L.P.S. Clavicle Plating System | HRS | Substantially Equivalent | |
| K192798 | Zimmer Segmental System | KRO | Substantially Equivalent | |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | MBI | Substantially Equivalent | |
| K193546 | Distal Centralizers | JDG | Substantially Equivalent | |
| K191449 | ZCA All-Poly Acetabular Cups | JDI | Substantially Equivalent | |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | JDI | Substantially Equivalent | |
| K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | HSB | Substantially Equivalent | |
| K193373 | Comprehensive® Reverse Shoulder | PHX | Substantially Equivalent | |
| K200112 | Zimmer Hip Joint Replacement | LZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1825034 | 1825034 | BIOMET, INC. | 56 E Bell Dr, WARSAW, IN 46581 US | 2026 | and 200 more, listed in full below |
| 9613350 | 3005233524 | ZIMMER GMBH | Sulzer Allee 8, WINTERTHUR Zurich CH-8404 CH | 2026 | and 53 more, listed in full below |
| 3013176080 | 3013176080 | ZIMMER PTE. LTD. | 401 Commonwealth Drive #06-03, Singapore South East 149598 SG | 2026 | and 72 more, listed in full below |
| 1822565 | 1000220733 | ZIMMER, INC. | 1800 W. Center Street, WARSAW, IN 46580 US | 2026 | and 132 more, listed in full below |
| 3035366890 | 3035366890 | Zimmer Biomet Pty Ltd | Level 4, 12 Narabang Way, Belrose, NSW, Sydney New South Wales 2085 AU | 2026 | and 92 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CACApparatus, Autotransfusion
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- GEFApplier, Staple, Surgical,
- FQMBandage, Elastic
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GESBlade, Scalpel
- DXQBlood Pressure Cuff
- FPSBoard, Bed
- GEACannula, Surgical, General & Plastic Surgery
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- FZPClip, Implantable
- FZSCurette, Surgical, General Use
- FZTCutter, Surgical
- GFDDermatome
- GXHDevice, Surgical, Cryogenic
- GFCDriver, Surgical, Pin
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- BXBExerciser, Powered
- FZWExpander, Surgical, Skin Graft
- FRLFiber, Medical, Absorbent
- GENForceps, General & Plastic Surgery
- EFQGauze/Sponge, Internal
- GDHGouge, Surgical, General & Plastic Surgery
- FYAGown, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- ESDHearing Aid, Air-Conduction, Prescription
- GDGHook, Surgical, General & Plastic Surgery
- DZEImplant, Endosseous, Root-Form
- GCJLaparoscope, General & Plastic Surgery
- FQHLavage, Jet
- EAYLight, Fiber Optic, Dental
- GFJMallet, Surgical, General & Plastic Surgery
- GXPMethyl Methacrylate For Cranioplasty
- GEYMotor, Surgical Instrument, Ac-Powered
- GABNeedle, Suturing, Disposable
- FWZOperating Room Accessories Table Tray
- GFIOsteotome, Manual
- GWOPlate, Cranioplasty, Preformed, Alterable
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- FRNPump, Infusion
- FMQRestraint, Protective
- GADRetractor
- GDRSaw, Manual And Accessories
- DZLScrew, Fixation, Intraosseous
- FLESterilizer, Steam
- ETNStimulator, Nerve
- CCXSupport, Patient Position
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
- BWNTable And Attachments, Operating-Room
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
- GAZTubing, Noninvasive
Recall records
Showing 25 of 2,495| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2871-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Class II | Open, Classified | |
| Z-2870-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Class II | Open, Classified | |
| Z-2869-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Class II | Open, Classified | |
| Z-2868-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Class II | Open, Classified | |
| Z-2867-2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade. | Class II | Open, Classified | |
| Z-2531-2026 | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Class II | Open, Classified | |
| Z-2530-2026 | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Class II | Open, Classified | |
| Z-2529-2026 | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Class II | Open, Classified | |
| Z-2528-2026 | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Class II | Open, Classified | |
| Z-2527-2026 | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Class II | Open, Classified | |
| Z-2578-2026 | Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision Trabecular Metal Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. | Class II | Open, Classified | |
| Z-1946-2026 | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A | Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention. | Class II | Open, Classified | |
| Z-0983-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0982-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0981-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0980-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0979-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0978-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0977-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0976-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0975-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0974-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0973-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0972-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified | |
| Z-0971-2026 | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain