Recall Z-0415-2013— Biomet, Inc.

Name: FDA recall Z-0415-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-04

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2012-10-04, terminated 2013-03-18. It names one FDA 510(k) clearance: K050124. Product: 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. Reason: The color code on label conflicts with the liner size (liner size 24 should be green, not yellow).

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-04
Terminated: 2013-03-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K050124 — POROUS COATED ACETABULAR COMPONENTSBiomet, Inc.·cleared 2005-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.