Device product
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Z-0536-2013
Product summary
- Firm
- Ebi, Llc
- Event
- Event 63653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0536-2013
Official wording
Reason: Broken screw insertor hardness was measured and found to be below the acceptable limits.
Code information: Lot Numbers 540199, 540199-1
Distribution pattern: Nationwide Distribution, including the states of MO, TX, and IN.
Derived failure modes
-
Unknown
Broken screw insertor hardness was measured and found to be below the acceptable limits.