Date Initiated by Firm | October 17, 2006 |
Date Posted | September 21, 2007 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number | Z-1241-2007 |
Recall Event ID |
38814 |
510(K)Number | K920034 |
Product Classification |
Knee Femoral Component - Product Code JWH
|
Product | Duracon Total Knee Modular Femoral Component;
Non-Porous Right Medium Assembly, Product No. 6632-0-325 |
Code Information |
Product No. 6632-0-325; Lot code UCVO |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact | Larry Ross 201-831-5972 |
Manufacturer Reason for Recall | Loose fixation pegs: One lot of femoral components may have loose fixation pegs. |
FDA Determined Cause 2 | Other |
Action | Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product. |
Quantity in Commerce | 3 total, 2 in USA |
Distribution | Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden. |
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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510(K) Database | 510(K)s with Product Code = JWH
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