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U.S. Department of Health and Human Services

Class 2 Device Recall Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup

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  Class 2 Device Recall Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup see related information
Date Initiated by Firm July 12, 2007
Date Posted October 25, 2007
Recall Status1 Terminated 3 on February 02, 2010
Recall Number Z-0020-2008
Recall Event ID 39402
PMA Number P040033 
Product Classification Hip implant acetabular component. - Product Code LXH
Product Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.
Code Information Lot Numbers: 65654, 64188, 67081, 67582, 67421, 67945, 68035
Recalling Firm/
Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Victor Rocha
Manufacturer Reason
for Recall
The carton label may not reflect the correct size of the acetabular cup.
FDA Determined
Cause 2
Packaging process control
Action The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.
Quantity in Commerce 10 units
Distribution Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
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.