Recall archive
84 recalls · page 1 of 4
Reported Jul 1, 2026
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 6, 2026
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the…
FDA (openFDA device enforcement)
Reported Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details · Reason for recall — Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 2, 2025
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6"…
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Z1 Femoral Hip System, Product Number 611777612
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
FDA (openFDA device enforcement)
Reported Feb 5, 2025
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail…
FDA (openFDA device enforcement)
Reported Aug 7, 2024
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
FDA (openFDA device enforcement)
Reported May 8, 2024
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be…
20 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2024
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate,…
FDA (openFDA device enforcement)
Reported Sep 13, 2023
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
FDA (openFDA device enforcement)
Reported Aug 9, 2023
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be…
FDA (openFDA device enforcement)
Reported Jul 12, 2023
NexGen Precoat Stemmed Tibial Plate Size 5
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Device outer packaging was incorrectly labeled.
FDA (openFDA device enforcement)
Reported Apr 5, 2023
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the…
FDA (openFDA device enforcement)
Reported Feb 15, 2023
Identity Shoulder System Resection Planer 35mm Resection Planer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Two planers were found to be unusable during sawbones shoulder training.
FDA (openFDA device enforcement)
Reported Dec 21, 2022
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2022
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during…
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2015
Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — Complaints that the ratchet teeth of the tube are not latching onto the rod.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2015
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details · Reason for recall — It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel…
FDA (openFDA device enforcement)
Reported Oct 7, 2015
Zimmer Guide Wires for orthopedic procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand · Product · Product details — Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing…
FDA (openFDA device enforcement)
Reported Jul 22, 2015
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer, Inc.
Matched: Brand — A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing,…
FDA (openFDA device enforcement)
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