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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 Recall
Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup
see related information
Date Posted October 25, 2007
Recall Status1 Terminated on February 02, 2010
Recall Number Z-0031-2008
Recall Event ID 39402
Premarket Approval
PMA Number
P040033
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component.
Code Information Lot Number 64868
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E Brooks Rd
Memphis, Tennessee 38116-1804
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall
The carton label may not reflect the correct size of the acetabular cup.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 1 unit
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 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.
PMA Database PMAs with Product Code = LXH and Applicant = SMITH & NEPHEW, INC.
PMAs with Product Code = LXH and Applicant = SMITH&NEPHEW ORTHOPAEDICS
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