Recall archive
84 recalls · page 2 of 4
Reported Jul 8, 2015
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in…
FDA (openFDA device enforcement)
Reported Jun 17, 2015
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than…
FDA (openFDA device enforcement)
Reported Jun 10, 2015
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2015
NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the…
FDA (openFDA device enforcement)
Reported Apr 8, 2015
Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being…
FDA (openFDA device enforcement)
Reported Mar 18, 2015
Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — An increase in complaints of loosening and radiolucent lines.
FDA (openFDA device enforcement)
Reported Mar 11, 2015
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
FDA (openFDA device enforcement)
Reported Feb 11, 2015
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 7, 2015
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal…
FDA (openFDA device enforcement)
Reported Dec 31, 2014
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one…
FDA (openFDA device enforcement)
Reported Dec 17, 2014
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the…
FDA (openFDA device enforcement)
Reported Dec 3, 2014
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2014
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Cleaning process validation failure.
FDA (openFDA device enforcement)
Reported Oct 29, 2014
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The affected products are missing polar boss threads.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2014
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm…
FDA (openFDA device enforcement)
Reported Sep 10, 2014
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated.…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2014
Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2014
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details · Reason for recall — Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 20, 2014
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2014
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."
FDA (openFDA device enforcement)
Reported Aug 6, 2014
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details · Reason for recall — Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due…
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2014
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
8 more products in this recall
FDA (openFDA device enforcement)
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