Osteomed, LLC
Osteomed, LLC has 3 FDA enforcement events on this register (15 product records) between 2020 and 2023: 3 device; the busiest year was 2020 with 1.
0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in TX.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 31 May 2023 | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile | Device | Class II | 2 | Ongoing |
| 28 Oct 2021 | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i… | Device | Class II | 1 | Ongoing |
| 2 Apr 2020 | OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. | Device | Class II | 12 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Osteomed, LLC had?
3 enforcement events (15 product records) on this register, 2020–2023: 3 device.
Are any Osteomed, LLC recalls ongoing?
2 events are listed as ongoing in the current openFDA export.
What class are Osteomed, LLC recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.