Recall Z-2190-2020 — OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
U.S. FDA — Device Enforcement · United States · 2020-04-02 · Class II
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Reported risk: 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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