Recall Z-0954-2013 ยท HXX Screwdriver
Ebi, Llc
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.
| Date | Mar 15, 2013 (initiated Feb 7, 2013) |
| Status | Terminated |
| Reason | Increased risk of failure at the driver tip during screw insertion or removal. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 59 units. |
| Distribution | Nationwide Distribution including the states of AL, IN, MO, NE TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.