Z-1689-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- April 26, 2019
- Termination Date
- April 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Reason for Recall
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
Distribution Pattern
OK, VA, FL
Code Information
UDI 10885862093219 Serial Numbers: T32309666, T32309672