Osteomed, LLC recalls
Every recall we track for Osteomed, LLC — 15 in all, from 2020–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Osteomed, LLC peaked in 2020 (12); 15 since 2017.
All FDA recall records for Osteomed, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 12 | 0 | 12 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 2 | 0 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Osteomed, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Osteomed, LLC recalls
3 shown- Use cautionMedical device
Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Osteomed recalls sterile surgical screws with a potential risk of the screw passing through the plate hole during osteotomies. Affected units include specific lot numbers and model designations.
OsteomedMay 31, 2023 - Use cautionMedical device
Osteomed, LLC recalls OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control
Osteomed recalls OsteoPower Power Console 2 and 2i models due to electrical safety compliance issues with IEC 60601 standards, which may have caused patient shocks. Affected units include specific model numbers and serial numbers listed in the recall notice.
OsteomedOct 28, 2021 - Lower riskMedical device
Osteomed, LLC recalls OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void
Osteomed recalls OSTEOVATIONEX 3CC bone void filler kits that may not maintain setting characteristics for the labeled shelf-life. Affected kits have specific lot numbers.
OsteomedApr 2, 2020
Osteomed, LLC recall questions
How many recalls has Osteomed, LLC had?
15 recalls from Osteomed, LLC are on record with U.S. safety agencies, from 2020–2023.
What is the most recent Osteomed, LLC recall?
Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile, dated May 31, 2023. Every Osteomed, LLC recall is listed on this page, newest first.
What should I do if I have a recalled Osteomed, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Osteomed, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.