Data / Medical devices / Switzerland / Zimmer GMBH
Zimmer GMBH: FDA-registered device maker in WINTERTHUR Zurich, Switzerland, 67 510(k) clearances
Zimmer GMBH is registered with the FDA (registration 9613350) in WINTERTHUR Zurich, Switzerland. It lists 62 device types. The FDA files 67 510(k) clearances under its listings, the newest dated April 27, 2026. 14 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9613350
- FEI number
- 3005233524
- Address
- Sulzer Allee 8, WINTERTHUR Zurich, Switzerland, CH-8404
- Owner or operator
- ZIMMER GMBH (9064978)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 8, 1996
- Registered through
- 2027
- Brand names listed
- ARCOMXL Polyethylene Liners and BIOLOX Delta Heads, ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System, Affixus Humeral Stem, Affixus Natural Nail Proximal Humeral System, Affixus® Natural Nail® System Humeral Nail, Alloclassic Zweymueller SL/SLL Femo, Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem, Anatomica Glenoid Component and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2026 | K260182 | Avenir® Müller Stem; Avenir Complete Hip System | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| December 12, 2025 | K253749 | Affixus® Natural Nail® Proximal Humeral System | HSB | Substantially Equivalent | Zimmer Switzerland Manufacturing GmbH | accessdata.fda.gov |
| August 15, 2024 | K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate | HRS | Substantially Equivalent | Zimmer Switzerland Manufacturing GmbH | accessdata.fda.gov |
| August 9, 2023 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System | HSB | Substantially Equivalent | Zimmer Switzerland Manufacturing GmbH | accessdata.fda.gov |
| September 28, 2021 | K212129 | Persona® Personalized Knee System | JWH | Substantially Equivalent | Zimmer Switzerland Manufacturing GmbH | accessdata.fda.gov |
| April 28, 2020 | K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| April 10, 2020 | K200112 | Zimmer Hip Joint Replacement | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| January 29, 2020 | K193099 | Anatomical Shoulder System | PHX | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 26, 2019 | K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 6, 2019 | K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| November 5, 2019 | K192236 | Fitmore Hip Stem | KWY | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 11, 2019 | K192312 | Zimmer Natural Nail System Cephalomedullary Nails | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 1, 2019 | K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| September 13, 2019 | K192217 | NCB Plating System Distal Femur and Proximal Tibia | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| August 22, 2019 | K192021 | NCB Polyaxial Locking Plate System | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| August 6, 2019 | K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 14, 2018 | K181827 | Affixus Natural Nail System Humeral Nail | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 18, 2017 | K171858 | Sidus Stem-Free Shoulder | PKC | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| June 1, 2017 | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | PHX | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| February 7, 2017 | K170072 | Fitmore® Hip Stem | KWY | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| November 1, 2016 | K161620 | Anatomical Shoulder Domelock Dome centric | HSD | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| July 8, 2016 | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 8, 2016 | K160085 | Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System | KWS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 2, 2016 | K151708 | RECON system - Compression Screws | HWC | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| January 26, 2016 | K151701 | Tenodesis screw system | HWC | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| November 5, 2015 | K152256 | RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws | HRS | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| October 30, 2015 | K152312 | RECON system-V-TEK-IVP Plates and Screws | HRS | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| September 16, 2015 | K152142 | RECON system - MPJ-Plates | HRS | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| August 12, 2015 | K151407 | RECON system | HRS | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| November 24, 2014 | K142403 | Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System | KWS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| July 3, 2014 | K140962 | NORMED VARIO SUBTALAR SCREW | HWC | Substantially Equivalent | Normed Nedizin Technik GmbH | accessdata.fda.gov |
| August 22, 2013 | K131884 | AVENIR CEMENTED HIP STEM | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| August 2, 2013 | K123347 | NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 | HRS | Substantially Equivalent | Normed Medizin-Technik GmbH | accessdata.fda.gov |
| May 1, 2013 | K130899 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 4, 2013 | K123392 | AVENIR MULLER STEM | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| August 10, 2012 | K120715 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| June 12, 2012 | K120772 | NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| February 17, 2012 | K113556 | WAGNER CONE PROSTHESIS SYSTEM | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| January 27, 2012 | K113718 | NCB STRAIGHT NARROW SHAFT PLATES | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 26, 2011 | K112174 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 7, 2011 | K110836 | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | KWA | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 15, 2011 | K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM | KWT | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| April 12, 2010 | K100111 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 28, 2009 | K091566 | ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 16, 2008 | K081759 | NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 13, 2008 | K073567 | BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES | LZO | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| March 7, 2008 | K071723 | ZIMMER POROLOCK MIS STEM | KWA | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| November 19, 2007 | K071535 | BIOLOX DELTA CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 31, 2006 | K062029 | ANATOMICAL SHOULDER FRACTURE SYSTEM | KWS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| June 14, 2006 | K061211 | NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| January 25, 2006 | K053274 | ANATOMICAL SHOULDER INVERSE/REVERSE | PHX | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 19, 2005 | K052906 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| July 19, 2005 | K051623 | ANATOMICAL SHOULDER KEELED GLENOID | KWS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| April 18, 2005 | K043356 | WAGNER SL REVISION STEM LATERAL | LZO | Substantially Equivalent | Zimmer Austin, Inc. | accessdata.fda.gov |
| January 31, 2005 | K043270 | SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES | HSB | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| October 29, 2004 | K042695 | NCB PLATING SYSTEM | HRS | Substantially Equivalent | Zimmer GmbH | accessdata.fda.gov |
| December 17, 2003 | K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM | LZO | Substantially Equivalent | Centerpulse Orthopedics, Inc. | accessdata.fda.gov |
| September 22, 2003 | K032380 | WAGNER CONE PROSTHESIS | LZO | Substantially Equivalent | Centerpulse Orthopedics, Inc. | accessdata.fda.gov |
| April 24, 2003 | K030259 | AMATOMICAL SHOULDER WITH REMOVABLE HEAD | KWS | Substantially Equivalent | Centerplus Orthopedics, Inc. | accessdata.fda.gov |
| March 6, 2003 | K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM | LZO | Substantially Equivalent | Centerpulse Orthopedics, Inc. | accessdata.fda.gov |
| February 28, 2001 | K003801 | ANATOMICAL PRESS-FIT HUMERAL STEM | KWS | Substantially Equivalent | Sulzer Orthopedics, Inc. | accessdata.fda.gov |
| June 23, 2000 | K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM | JDI | Substantially Equivalent | Sulzer Orthopedics, Inc. | accessdata.fda.gov |
| March 10, 2000 | K993259 | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS | LPH | Substantially Equivalent | Sulzer Orthopedics, Inc. | accessdata.fda.gov |
| March 1, 1999 | K990136 | ANATOMICA GLENOID COMPONENT | KWS | Substantially Equivalent | Sulzer Orthopedics, Inc. | accessdata.fda.gov |
| August 19, 1996 | K962101 | ZWEYMUELLER SL FEMORAL HIP STEM | LZO | Substantially Equivalent | Intermedics Orthopedics | accessdata.fda.gov |
| August 5, 1996 | K960588 | WAGNER REVISION STEM | LZO | Substantially Equivalent | Intermedics Orthopedics | accessdata.fda.gov |
| July 1, 1987 | K871347 | WAGNER REVISIONAL FEMORAL HIP PROSTHESIS | JDI | Substantially Equivalent | Protek, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 8, 2024 | 95231 | Class II | Ongoing | Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6 | accessdata.fda.gov |
| May 7, 2021 | 87924 | Class II | Terminated | Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11 | Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree | accessdata.fda.gov |
| August 21, 2019 | 83689 | Class II | Terminated | Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoul | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. | accessdata.fda.gov |
| April 8, 2019 | 82642 | Class II | Terminated | Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106 | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | accessdata.fda.gov |
| October 31, 2018 | 81608 | Class II | Terminated | Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of to | Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2. | accessdata.fda.gov |
| March 15, 2018 | 79495 | Class II | Terminated | Normed Charcot Osteotome Chisel (Various sizes) | Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use. | accessdata.fda.gov |
| February 28, 2018 | 79677 | Class II | Terminated | Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368 | A potential commingle that could result in the product in the package not matching the product on the outer label. | accessdata.fda.gov |
| May 11, 2017 | 77262 | Class II | Terminated | Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over | the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage. | accessdata.fda.gov |
| June 30, 2016 | 74693 | Class II | Terminated | Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-t | Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision. | accessdata.fda.gov |
| June 27, 2016 | 74548 | Class II | Terminated | TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems. | Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component. | accessdata.fda.gov |
| May 17, 2016 | 74206 | Class II | Terminated | Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. | In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon | accessdata.fda.gov |
| September 3, 2015 | 72123 | Class II | Terminated | Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. | In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to | accessdata.fda.gov |
| March 18, 2015 | 70993 | Class II | Terminated | Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder. | Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery. | accessdata.fda.gov |
| December 17, 2014 | 70401 | Class II | Terminated | CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty. | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision. | accessdata.fda.gov |
Compare with other makers
- All makers of Rasp
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- All makers of Awl
Updated April 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.