FDA Enforcement
Class II
Terminated
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.
Recall: Z-1091-2019
·
Reported April 17, 2019
Enforcement
- Recall Number
- Z-1091-2019
- Event ID
- 82361
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 17, 2019
- Initiation Date
- March 1, 2019
- Classification Date
- April 5, 2019
- Termination Date
- June 22, 2020
- Address
- 311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States
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
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 Info
Lot Number: FGD8329
Distribution
US Nationwide distribution in the states of OH, MI.
Quantity
232 total