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.
FDA Recall Z-0954-2013 · Posted 2013-03-15
Recalling FirmEbi, Llc
Recall StatusTerminated
Product CodeHXX
Date Initiated2013-02-07
Date Terminated2015-12-07
Product Quantity59 units.
Reason for Recall
Increased risk of failure at the driver tip during screw insertion or removal.
Firm 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 Friday, 8am to 5pm.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.