| |
Class 3 Device Recall Genesis II |
 |
| Date Initiated by Firm |
April 12, 2006 |
| Date Posted |
June 17, 2006 |
| Recall Status1 |
Terminated 3 on April 11, 2007 |
| Recall Number |
Z-1157-06 |
| Recall Event ID |
35492 |
| 510(K)Number |
K926557
|
| Product Classification |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer - Product Code HSX
|
| Product |
Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 right, Part No. 71420152 |
| Code Information |
05LM01939 |
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 |
Mispackaging-A size 5 femoral component, left, box had a size 5 right component in the box.
|
FDA Determined
Cause 2 |
Other |
| Action |
All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006. |
| Quantity in Commerce |
3 units |
| Distribution |
Worldwide-including states of
LA, NC, IN, and countries of France, and Turkey |
| 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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