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U.S. Department of Health and Human Services

Class 2 Device Recall Ranawat/Burnstein Acetabular Shell

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 Class 2 Recall
Ranawat/Burnstein Acetabular Shell
see related information
Date Posted November 21, 2012
Recall Status1 Terminated on March 18, 2013
Recall Number Z-0415-2013
Recall Event ID 63613
Premarket Notification
510(K) Number
K050124 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
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
Code Information Part 11-106054 Lot 528310
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action 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.
Quantity in Commerce 16 (5 USA)
Distribution Nationwide Distribution including CA, IN, NC, OH, and UT.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = BIOMET, INC.
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