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

• Date Initiated by Firm: July 12, 2007
• Date Posted: October 25, 2007
• Recall Status: Terminated on February 02, 2010
• Recall Number: Z-0021-2008
• Recall Event ID: 39402
• PMA Number: P040033
• Product Classification: Hip implant acetabular component. - Product Code LXH
• Product: Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component.
• Code Information: Lot Numbers: 64797, 64798, 64846, 65084, 67553, 67555, 67557, 67871, 67388, 67589, 67706
• 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 may not reflect the correct size of the acetabular cup.
• FDA Determined Cause: 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: 21 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.