Biomet, 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
Read the official notice →- Date
- 2023-11-29
- Country
- United States
- Brand
- Biomet
- Product
- Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of ARGENTINA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-07-03
US
Biomet, Inc. recalls RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
FDA · DeviceBiomet, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA…Official notice →- 2024-05-01
US
Biomet, Inc. recalls Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with…
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
FDA · DeviceBiomet, Inc.Worldwide distribution - US Nationwide in the state of IN and the countries of…Official notice →- 2023-12-27
US
Biomet, Inc. recalls Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck…
FDA · DeviceBiomet, Inc.US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.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
Other drugs & medical recalls in the United States
- 2023-11-29
US
LEONI CIA CABLE SYSTEMS recalls ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy,…
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen…
FDA · DeviceLEONI CIA CABLE SYSTEMSUS Nationwide distribution in the states of MA, TN.Official notice →US
Boston Scientific Corporation recalls EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Poor image quality due to fluid ingress in the lens.
FDA · DeviceBoston Scientific CorporationWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →US
Philips North America Llc recalls SmartPath to dStream for 1.5T
Potential component failure in the Gradient Coil could product smoke and/or fire.
FDA · DevicePhilips North America LlcDomestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina,…Official notice →US
SunMed Holdings, LLC recalls Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s:…
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
FDA · DeviceSunMed Holdings, LLCUS Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL,…Official notice →US
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product…
US
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled…