—#114365

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

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K050124
Affected lot / code info: Part 11-106054 Lot 528310

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

BIOMET called distributors who received the affected product to return it to Biomet with follow-up Urgent Recall Notices sent via E-mail October 22, 2012.. The notice included the identity of the recalled device, reason for the recall, and directions to complete the FAX back form and return it to 574-372-1683. Product is to be returned to Return Goods, Recalls, Biomet, Inc. 56 East Bell Drive, Warsaw, IN 46580. Questions related to the recall should be directed to Field Action Coordinator (574) 372-1570, Monday through Friday. 8 a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2012-10-04
Posted by FDA: 2012-11-21
Terminated: 2013-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114365. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.