Device product
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
Z-0954-2013
Product summary
- Firm
- Ebi, Llc
- Event
- Event 64452
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 units.
- Official record key
device-enforcement:Z-0954-2013
Official wording
Reason: Increased risk of failure at the driver tip during screw insertion or removal.
Code information: Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
Distribution pattern: Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Derived failure modes
-
Unknown
Increased risk of failure at the driver tip during screw insertion or removal.