Recall Atlas

Osteomed recalls

2 official recalls and safety alerts involving Osteomed since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Osteomed or the relevant agency.

  1. 2023-07-19
  2. US
    Drugs & medicalClass II

    Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

    Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

    FDA · DeviceOsteomed, LLCWorldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS,…Official notice →
  3. 2021-12-15
  4. US
    Drugs & medicalClass II

    Osteomed, LLC recalls OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF…

    Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.

    FDA · DeviceOsteomed, LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice →