Ebi, Llc: Medical Device Recall in 2013 - (Recall #: Z-0359-2014)

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, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system

Product Classification:

Class II

Date Initiated: August 22, 2013

Date Posted: November 27, 2013

Recall Number: Z-0359-2014

Event ID: 66300

Reason for Recall:

Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

Status: Terminated

Product Quantity: 7,092 units

Code Information:

Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.

Distribution Pattern:

Nationwide distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated