Ebi, Llc: Medical Device Recall in 2013 - (Recall #: Z-0954-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 7, 2013

Date Posted: March 27, 2013

Recall Number: Z-0954-2013

Event ID: 64452

Reason for Recall:

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

Status: Terminated

Product Quantity: 59 units.

Code Information:

Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated