Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in th...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1396-2015.
Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1396-2015.
Recall terminated by FDA.
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1396-2015.
Bacterin International, Inc.
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Bacterin International, Inc. Recall FAQ
Bacterin International, Inc. is the subject of a medical devices safety report: Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in th.... The notice was published on March 9, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 63 units are potentially affected.