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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-0024-2008
Recall Event ID 39402
Premarket Approval
PMA Number
P040033
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
Code Information Lot Numbers: 65655, 64496, 65081, 66111, 67874, 67477, 67925, 67940
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 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 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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