Recall archive
156 recalls · page 2 of 7
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 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)
Reported Apr 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
32 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2020
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0)…
FDA (openFDA device enforcement)
Reported Apr 1, 2020
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand — A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
FDA (openFDA device enforcement)
Reported Mar 4, 2020
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the…
FDA (openFDA device enforcement)
Reported Feb 12, 2020
Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2020
ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
FDA (openFDA device enforcement)
Reported Dec 11, 2019
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2019
ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2019
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
40 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2019
XP- CR Tibial Tray- Interlok 59mm Item # 195268
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The locking bar not fully engaging
34 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2019
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Cleaning processes potentially being ineffective
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Lack of an adequate sterilization validation.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2019
DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — There is a potential for weak seals of the sterile packaging.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2019
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm…
FDA (openFDA device enforcement)
Reported Jun 12, 2019
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2019
T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — There is a potential of fracture, bending or shearing of the driver.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2019
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — Lack of an adequate sterilization validation
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2019
Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Product · Product details — The product was potentially being packaged without a taper adapter.
FDA (openFDA device enforcement)
Reported Mar 6, 2019
Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 23, 2019
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — There is a potential for silicone shedding during cleaning and sterilization.
1 more product in this recall
FDA (openFDA device enforcement)
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