Ebi, Llc: Medical Device Recall in 2012 - (Recall #: Z-0536-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Product Classification:

Class II

Date Initiated: September 29, 2012

Date Posted: December 26, 2012

Recall Number: Z-0536-2013

Event ID: 63653

Reason for Recall:

Broken screw insertor hardness was measured and found to be below the acceptable limits.

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot Numbers 540199, 540199-1

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated