Device product
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
Z-1090-2019
Product summary
- Firm
- Integra Limited
- Event
- Event 82361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 232 total
- Official record key
device-enforcement:Z-1090-2019
Official wording
Reason: 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
Code information: Lot Numbers: FGD2096, FGD8328
Distribution pattern: US Nationwide distribution in the states of OH, MI.
Derived failure modes
-
Unknown
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