Home / Recalls / Medical Devices
Integra Limited recalls Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is in
Recalled April 17, 2019 · FDA recall Z-1091-2019 · Integra
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 · FDA Class II
Units
232 total
Sold at
US Nationwide distribution in the states of OH, MI.
Description
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
Product
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.
Manufacturer(s)
Integra Limited
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →