Biomet, Inc. recalls Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a…
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and…
Read the official notice →- Date
- 2023-02-01
- Country
- United States
- Brand
- Biomet
- Product
- Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of IN, KY…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Biomet recalls
- 2023-11-29
USBiomet, Inc. recalls Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.…
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
FDA · DeviceBiomet, Inc.Worldwide distribution - US Nationwide and the countries of ARGENTINA,…Official notice →- 2023-03-29
- US
Biomet, Inc. recalls G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
- 2023-02-08
- US
Biomet, Inc. recalls (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED…
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
FDA · DeviceBiomet, Inc.International distribution to the countries of: Argentina, China, Costa Rica,…Official notice → - US
Biomet, Inc. recalls OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone,…
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
- 2022-03-30
- US
Biomet, Inc. recalls BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which…
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of…
FDA · DeviceBiomet, Inc.Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA,…Official notice → - 2022-03-02
- US
Biomet, Inc. recalls Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be…
FDA · DeviceBiomet, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Ecuador,…Official notice →
Other drugs & medical recalls in the United States
- 2023-02-08
- US
Colgate-Palmolive Recalls Fabuloso Multi-Purpose Cleaners Due to Risk of Exposure to Bacteria
The recalled products can contain Pseudomonas species bacteria, including Pseudomonas aeruginosa and Pseudomonas fluorescens, which are environmental organisms found widely in soil and water. People with weakened…
CPSCColgate-Palmolive Company, of New YorkAbout 4.9 million (In addition, about 56,000 in Canada)Official notice → - 2023-02-01
- US
Biokit, S.A. recalls biokitHSV-2 Rapid Test, REF: 300028001
HSV-2 rapid test may report false positive results.
FDA · DeviceBiokit, S.A.US Nationwide distribution in the states of NY, CA, IN, NC, VA.Official notice → - US
SunMed Holdings, LLC recalls Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305…
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may…
FDA · DeviceSunMed Holdings, LLCUS Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.Official notice → - US
Align Technology Inc recalls Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
FDA · DeviceAlign Technology IncU.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY,…Official notice → - US
Future Diagnostics Solutions B.V. recalls Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
FDA · DeviceFuture Diagnostics Solutions B.V.Worldwide distribution. US states of AZ, CA, CO, LA, OH, PA, and TX; Austria,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
The kit contained an expired component.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of NY, IN, FL, NJ, IL.Official notice →