Device product
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Z-1081-2019
Product summary
- Event
- Event 82324
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89 units
- Official record key
device-enforcement:Z-1081-2019
Official wording
Reason: Lack of an adequate sterilization validation
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Lack of an adequate sterilization validation