Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervic

FDA device recall Z-0954-2013 · posted 2013-03-15 · Terminated

Recall details

Recalling firm

Ebi, Llc

Reason for recall

Increased risk of failure at the driver tip during screw insertion or removal.

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.

Root cause

Process control

Status

Terminated

Product code

HXX

Quantity affected

59 units.

Distribution

Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.

Date initiated

2013-02-07

Date posted

2013-03-15

Date terminated

2015-12-07

Location

Parsippany, NJ