co_sos
1 records
fda
11 records
FDA Recall: Osteomed, LLC — Class II
20230719
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. | Product: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
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FDA Device Recall: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
2023-07-19
Class II — Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
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FDA Device Recall: REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Steri
2023-07-19
Class II — Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
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FDA Recall: Osteomed, LLC — Class II
20200610
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. | Product: OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-...
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FDA Device Recall: OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usa
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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FDA Device Recall: OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage:
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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FDA Device Recall: OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Produc
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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FDA Device Recall: OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usa
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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FDA Device Recall: OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usag
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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FDA Device Recall: OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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FDA Device Recall: OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product U
2020-06-10
Class II — Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
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ny_corps
1 records
NY Corp: OSTEOMED LLC
2012-05-14
FOREIGN LIMITED LIABILITY COMPANY | County: Albany | Jurisdiction: Delaware
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