Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Osteomed with 73 510(k) clearances and 15 device recalls. The most recent is a device recall dated May 31, 2023: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 31, 2023 | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileClass II · Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. | Device recalls |
| May 31, 2023 | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, SterileClass II · Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. | Device recalls |
| Feb 11, 2022 | OsteoPlan SystemK212570 · DZJ | 510(k) clearances |
| Oct 28, 2021 | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021Class II · Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patien | Device recalls |
| Feb 24, 2021 | ExtremiLOCK Lateral Ankle Fusion PlatesK203479 · HRS | 510(k) clearances |
| Oct 29, 2020 | OsteoMed ExtremiFix Mini & Small System TrayK202105 · KCT | 510(k) clearances |
| Oct 15, 2020 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemK202680 · HWC | 510(k) clearances |
| Apr 2, 2020 | OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replacedClass II · Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled | Device recalls |
| Apr 2, 2020 | OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced byClass II · Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled | Device recalls |
| Apr 2, 2020 | OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is repClass II · Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled | Device recalls |
| Apr 2, 2020 | OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replacedClass II · Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled | Device recalls |
| Apr 2, 2020 | OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced Class II · Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled | Device recalls |
| May 10, 2018 | OsteoMed QuickFix Hybrid MMF Sterilization TrayK173391 · KCT | 510(k) clearances |
| May 19, 2017 | OsteoMed PINNACLE DriverK162542 · HBE | 510(k) clearances |
| Apr 4, 2017 | OsteoMed ExtremiFix Mid and Large Screw SystemK163303 · HWC | 510(k) clearances |
| Apr 4, 2017 | OsteoMed PINNACLE DriverK162544 · KMW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
