Biomet, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0415-2013)

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:

Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered

Product Classification:

Class II

Date Initiated: October 4, 2012

Date Posted: November 28, 2012

Recall Number: Z-0415-2013

Event ID: 63613

Reason for Recall:

The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)

Status: Terminated

Product Quantity: 16 (5 USA)

Code Information:

Part 11-106054 Lot 528310

Distribution Pattern:

Nationwide Distribution including CA, IN, NC, OH, and UT.

Voluntary or Mandated:

Voluntary: Firm initiated