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Class 2 Device Recall Smith Nephew, Birmingham Hip Resurfacing, Acetabular Cup |
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| Date Initiated by Firm |
July 12, 2007 |
| Date Posted |
October 25, 2007 |
| Recall Status1 |
Terminated 3 on February 02, 2010 |
| Recall Number |
Z-0029-2008 |
| 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, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component. |
| Code Information |
Lot Numbers: 66612, 66999 |
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
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Manufacturer Reason
for Recall |
The carton label may not reflect the correct size of the acetabular cup.
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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 |
2 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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