Drugs & medicalClass II

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

Read the official notice →
Date
2023-02-08
Country
United States
Brand
Biomet
Product
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone,…
Classification
Class II
Units
US Nationwide distribution in the states of CA, KY, FL.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2023-11-29
  2. US
    Drugs & medicalClass II

    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

    FDA · DeviceBiomet, Inc.Worldwide distribution - US Nationwide and the countries of ARGENTINA,…Official notice →
  3. 2023-03-29
  4. US
    Drugs & medicalClass II

    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.

    FDA · DeviceBiomet, Inc.US Distribution to states of: AZ, FL, GA, MI, NE, and TX.Official notice →
  5. 2023-02-08
  6. US
    Drugs & medicalClass II

    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 →
  7. 2023-02-01
  8. US
    Drugs & medicalClass II

    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…

    FDA · DeviceBiomet, Inc.Worldwide distribution - US Nationwide distribution in the states of IN, KY…Official notice →
  9. 2022-03-30
  10. US
    Drugs & medicalClass II

    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 →
  11. 2022-03-02
  12. US
    Drugs & medicalClass II

    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 →
All 14 Biomet recalls →

Other drugs & medical recalls in the United States

  1. 2023-02-08
  2. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane…

    In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue…

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Medtronic Navigation, Inc. recalls AxiEM" Non-Invasive Patient Tracker

    Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.

    FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO,…Official notice →
  4. US
    Drugs & medicalClass II

    Turbett Surgical, Inc. recalls Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

    FDA · DeviceTurbett Surgical, Inc.US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA,…Official notice →
  5. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case

    Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AR, MD, WA, WI.Official notice →
  6. US
    Drugs & medicalClass II

    Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF…

    An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or…

    FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia,…Official notice →
  7. US
    Drugs & medicalClass II

    SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Due to tears reported tears in the cannula due to wear and tear stress.

    FDA · DeviceSynCardia Systems LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice →
See all drugs & medical recalls →