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U.S. Department of Health and Human Services

Class 2 Device Recall Reflection, Microstable Acetabular Liner

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  Class 2 Device Recall Reflection, Microstable Acetabular Liner see related information
Date Initiated by Firm November 21, 2008
Date Posted April 21, 2009
Recall Status1 Terminated 3 on November 21, 2011
Recall Number Z-1004-2009
Recall Event ID 50543
510(K)Number K991026  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
Code Information Part Number: 71740250, Lot Numbers: 08FM05400 and 08FM05400B.
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 Brooks Rd
Memphis TN 38116
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall		 Liners measuring 28 mm ID and were mismarked as 32 mm.
FDA Determined
Cause 2		 Process control
Action All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.
Quantity in Commerce 19 units
Distribution International Distribution to Canada, France, Germany and Switzerland.
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.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = SMITH & NEPHEW, INC.
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