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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

156 recalls · page 1 of 7

Medical devices

Reported Aug 12, 2026

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand · Reason for recallZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile…

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 29, 2025

BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand · Product · Product detailsThere is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

FDA (openFDA device enforcement)

Medical devices

Reported Oct 1, 2025

Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandThe outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.

FDA (openFDA device enforcement)

Medical devices

Reported Nov 27, 2024

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandFirm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find…

FDA (openFDA device enforcement)

Medical devices

Reported Jul 3, 2024

RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical…

FDA (openFDA device enforcement)

Medical devices

Reported May 1, 2024

Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandPossible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

FDA (openFDA device enforcement)

Medical devices

Reported Dec 27, 2023

Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandOne product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Nov 29, 2023

Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandAnchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in…

18 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 29, 2023

G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandThe outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

FDA (openFDA device enforcement)

Medical devices

Reported Feb 8, 2023

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandProduct missing the four small locking collar bolts resulting in extension of surgery to find a replacement

2 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 1, 2023

Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandPackaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch…

FDA (openFDA device enforcement)

Medical devices

Reported Mar 30, 2022

BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand · Product · Product detailsPackaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk…

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Mar 2, 2022

Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandThe products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may…

7 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Aug 18, 2021

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandArcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical…

16 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 24, 2021

Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand · Reason for recallZimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been…

FDA (openFDA device enforcement)

Medical devices

Reported Jan 27, 2021

A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandThe instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 30, 2020

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandIncorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

FDA (openFDA device enforcement)

Medical devices

Reported Dec 30, 2020

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer Biomet, Inc.

Matched: BrandDevice has the potential for fracture during use.

FDA (openFDA device enforcement)

Medical devices

Reported Dec 23, 2020

3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: BrandSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of…

15 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Dec 23, 2020

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer Biomet, Inc.

Matched: Brand · Reason for recallZimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal…

FDA (openFDA device enforcement)

Medical devices

Reported Nov 11, 2020

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer Biomet, Inc.

Matched: BrandSterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual…

74 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 21, 2020

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand · Product · Product detailsProduct potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter,…

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 14, 2020

Biomet Regenerex Primary Taper Cap Item Number 141269

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Biomet, Inc.

Matched: Brand · Product · Product detailsProduct not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 14, 2020

Dual Mobility Vivacit-E Bearing, Model Number 110031009

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zimmer Biomet, Inc.

Matched: BrandThe outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.

FDA (openFDA device enforcement)

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