Osteomed recalls
Osteomed appears in 15 official U.S. recall notices indexed by RecallRadar, most recently on 2023-07-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 15 |
|---|---|
| Published | 2020-06-10 to 2023-07-19 |
| By agency | FDA Device (15) |
| By classification | Class II (15) |
| By status | terminated (12), ongoing (3) |
| Distribution named in notices | US |
Recalls
- REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
FDA Device · Class II · 2023-07-19 · Osteomed
Reason: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. - REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
FDA Device · Class II · 2023-07-19 · Osteomed
Reason: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. - OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01…
FDA Device · Class II · 2021-12-15 · Osteomed
Reason: Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. - OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced b…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced b…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is repla…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replace…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION RMX 10 CC Injectable
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replace…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replace…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. - OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is re…
FDA Device · Class II · 2020-06-10 · Osteomed
Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.