Recall archive
15 recalls · page 1 of 1
Reported Sep 18, 2024
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand · Product · Product details · Reason for recall — Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2019
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand · Product details — Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
FDA (openFDA device enforcement)
Reported May 29, 2019
Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
75 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
FDA (openFDA device enforcement)
Reported May 2, 2018
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — A potential commingle that could result in the product in the package not matching the product on the outer label.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 18, 2018
Normed Charcot Osteotome Chisel (Various sizes)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
FDA (openFDA device enforcement)
Reported May 24, 2017
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device…
FDA (openFDA device enforcement)
Reported Aug 10, 2016
TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand · Reason for recall — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2016
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice…
FDA (openFDA device enforcement)
Reported Jun 22, 2016
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Oct 21, 2015
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported May 6, 2015
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle…
FDA (openFDA device enforcement)
Reported Mar 4, 2015
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Brand — 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…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2012
Alloclassic SL Shaft
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in…
39 more products in this recall
FDA (openFDA device enforcement)
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