FDAMarch 1, 2019device
Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
What to do
FDA enforcement status: Terminated
Brands named
integra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
- FDAPrivate Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.2026-01-16
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