Z-1089-2019 Class II Terminated
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, 10mm Catalog Number: 40010 - 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:FGD8327