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.
This recall has been terminated (originally issued March 15, 2013).
- Company
- Ebi, Llc
- Recall Initiated
- February 7, 2013
- Posted
- March 15, 2013
- Terminated
- December 7, 2015
- Recall Number
- Z-0954-2013
- Quantity
- 59 units.
- Firm Location
- Parsippany, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Increased risk of failure at the driver tip during screw insertion or removal.
Distribution
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Lot / Code Info
Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
Root Cause
Process control
Action Taken
Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC. Please follow the instructions on the enclosed "FAX Back Response Form, " and fax a copy of the Response Form to (973) 257-0232, prior to return of the items. Questions related to this notice should be directed to (973) 299-9300 ex. 2322. Monday through Friday, 8am to 5pm.