Recall archive
84 recalls · page 3 of 4
Reported Jul 2, 2014
VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem,…
FDA (openFDA device enforcement)
Reported May 21, 2014
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The shell was missing the locking ring.
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation.…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
Trabecular Metal" Reverse Shoulder System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2014
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico.…
43 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2014
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details · Reason for recall — After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product details — The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on…
FDA (openFDA device enforcement)
Reported Jan 8, 2014
FEM COND BUTTRESS PLT, RT.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2013
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer…
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2013
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2013
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product…
47 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2013
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2013
Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured…
FDA (openFDA device enforcement)
Reported Jul 10, 2013
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2013
Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
FDA (openFDA device enforcement)
Reported Jun 5, 2013
NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As…
FDA (openFDA device enforcement)
Reported Apr 10, 2013
Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch.…
FDA (openFDA device enforcement)
Reported Feb 13, 2013
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30%…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 16, 2013
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM…
FDA (openFDA device enforcement)
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