| Class 2 Device Recall Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup | |
Date Initiated by Firm | July 12, 2007 |
Date Posted | October 25, 2007 |
Recall Status1 |
Terminated 3 on February 02, 2010 |
Recall Number | Z-0027-2008 |
Recall Event ID |
39402 |
PMA Number | P040033 |
Product Classification |
Hip implant acetabular component. - Product Code LXH
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Product | Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component. |
Code Information |
Lot Numbers: 64178, 65670, 66424, 66802 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E Brooks Rd Memphis TN 38116-1804
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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 | 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 | 6 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 |
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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.
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