Recall archive
245 recalls · page 2 of 11
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: Brand — Product 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)
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: Brand — Packaged 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)
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: 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 Jul 6, 2022
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Changzhou Biomet Medical Devices Co., Ltd.
Matched: Brand — One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
FDA (openFDA device enforcement)
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 details — Packaging 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)
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: Brand — The 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)
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: Brand — Arcos 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)
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 recall — Zimmer 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)
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: Brand — The 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)
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: Brand — Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
FDA (openFDA device enforcement)
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: Brand — Device has the potential for fracture during use.
FDA (openFDA device enforcement)
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: Brand — Specific 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)
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 recall — Zimmer 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)
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: Brand — Sterilant (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)
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 details — Product 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)
Reported Oct 14, 2020
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data…
6 more products in this recall
FDA (openFDA device enforcement)
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 details — Product 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)
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: Brand — The 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)
Reported Jun 24, 2020
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet
Matched: Brand · Product · Product details — Device and tray that houses the device did not pass steam sterilization process validation testing
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery…
FDA (openFDA device enforcement)
Reported Jun 17, 2020
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet
Matched: Brand · Product · Product details — Distributed to the field without having completed design history files or design transfer activities
21 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2020
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw…
24 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2020
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — Potential presence of elevated endotoxin levels that exceed the specification limit
12 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 29, 2020
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
FDA (openFDA device enforcement)
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