Z-1091-2019 Class II Terminated
FDA device recall Z-1091-2019 was initiated by Integra Limited on March 1, 2019 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated June 22, 2020). Affected quantity: 232 total.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- March 1, 2019
- Termination Date
- June 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 232 total
Product Description
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.
Reason for Recall
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
Distribution Pattern
US Nationwide distribution in the states of OH, MI.
Code Information
Lot Number: FGD8329