||March 15, 2013
||Terminated on December 07, 2015
|Recall Event ID
||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.
||Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.
100 Interpace Pkwy
973-299-9300 Ext. 3904
|For Additional Information Contact
||Mr. David M. Talish
973-299-9300 Ext. 2322
|Increased risk of failure at the driver tip during screw insertion or removal.
||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.
|Quantity in Commerce
||Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.