Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1091-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2019-03-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1091-2019
Date of alert: 2019-03-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Integra Limited
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1091-2019 — 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.

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