Osteomed Recalls
15 recalls on record · June 10, 2020 to July 19, 2023 · Medical Devices
Recalls by year
20
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 19, 2023Medical DevicesFDA
Osteomed, LLC recalls REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Hazard: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
July 19, 2023Medical DevicesFDA
Osteomed, LLC recalls REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Hazard: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
December 15, 2021Medical DevicesFDA
Osteomed, LLC recalls OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Co
Hazard: Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void f
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void f
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone voi
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void fill
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void fill
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void fill
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void fille
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void fil
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void fil
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
June 10, 2020Medical DevicesFDA
Osteomed, LLC recalls OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void fil
Hazard: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.