Zimmer GmbH

FDA recalling firm · 14 enforcement events · 99 product records · 2014–2024 · N/A

Zimmer GmbH has 14 FDA enforcement events on this register (99 product records) between 2014 and 2024: 14 device; the busiest year was 2016 with 3.

0% of its events are Class I; the most common class is Class II (14). 1 event is listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
8 Aug 2024	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: 650-1066	Device	Class II	2	Ongoing
7 May 2021	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	Device	Class II	2	Terminated
21 Aug 2019	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 shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder…	Device	Class II	1	Terminated
8 Apr 2019	Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106	Device	Class II	76	Terminated
31 Oct 2018	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 total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the…	Device	Class II	1	Terminated
15 Mar 2018	Normed Charcot Osteotome Chisel (Various sizes)	Device	Class II	1	Terminated
28 Feb 2018	Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368	Device	Class II	2	Terminated
11 May 2017	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 guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to…	Device	Class II	1	Terminated
30 Jun 2016	Avenir M¿ller Stem 4 Standard Avenir M¿ller 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-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction…	Device	Class II	1	Terminated
27 Jun 2016	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.	Device	Class II	4	Terminated
17 May 2016	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. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder…	Device	Class II	1	Terminated
3 Sep 2015	Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.	Device	Class II	1	Terminated
18 Mar 2015	Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.	Device	Class II	1	Terminated
17 Dec 2014	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.	Device	Class II	5	Terminated

By type and class

Device14

Class II14

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Zimmer GmbH by year initiated.

Questions and answers

How many FDA recalls has Zimmer GmbH had?

14 enforcement events (99 product records) on this register, 2014–2024: 14 device.

Are any Zimmer GmbH recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Zimmer GmbH recalls?

14 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.