Recall archive
245 recalls · page 3 of 11
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
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or…
22 more products in this recall
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 Oct 9, 2019
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer GmbH
Matched: Product details — Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
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 Aug 14, 2019
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet 3i, LLC
Matched: Brand · Product · Product details — During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2019
PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Getinge US Sales LLC
Matched: Product details — The monitor displays an error message . The error message states "internal error restart or service".
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 Jun 5, 2019
Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Surgical Inc.
Matched: Product · Product details — Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II Base Plate and Foot Piece due to potentially…
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
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet Spine Inc.
Matched: Brand — The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a…
2 more products in this recall
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up