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U.S. Department of Health and Human Services

Class 2 Device Recall BHR Acetabular Cup W/ Impactor

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  Class 2 Device Recall BHR Acetabular Cup W/ Impactor see related information
Date Initiated by Firm March 13, 2007
Date Posted June 07, 2007
Recall Status1 Terminated 3 on October 28, 2011
Recall Number Z-0863-2007
Recall Event ID 37782
PMA Number P040033 
Product Classification hip prosthesis - Product Code LXH
Product Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150
Code Information Lot Number: 64603
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall		 The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
FDA Determined
Cause 2		 Other
Action The consignees (hospital CEOs) were notified of the problem and the recall by letter (Fed Ex) on 03/13/2007.
Quantity in Commerce 1 unit
Distribution Europe. No domestic distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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