FDAApril 1, 2020device
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
What to do
FDA enforcement status: Terminated
Brands named
howmedica osteonicshowmedica
UPCs
0080823200096200808232000979
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDA1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;2025-08-28
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- FDAMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 2090632024-08-07
- FDACustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;2024-08-05
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