Z-0954-2013 Class II Terminated
FDA device recall Z-0954-2013 was initiated by Ebi, Llc on February 7, 2013 and is designated Class II. Reason for recall: Increased risk of failure at the driver tip during screw insertion or removal. The recall status is terminated (terminated December 7, 2015). Affected quantity: 59 units..
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2013
- Initiation Date
- February 7, 2013
- Termination Date
- December 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units.
Product Description
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.
Reason for Recall
Increased risk of failure at the driver tip during screw insertion or removal.
Distribution Pattern
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Code Information
Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.