Date Initiated by Firm |
August 20, 2007 |
Date Posted |
March 16, 2010 |
Recall Status1 |
Terminated 3 on March 16, 2010 |
Recall Number |
Z-1141-2010 |
Recall Event ID |
50102 |
510(K)Number |
K030978
|
Product Classification |
knee prosthesis - Product Code JWH
|
Product |
Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R.
Mahwah, NJ |
Code Information |
Product Code: 814407R; Lot Code: L65MKD |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430
|
For Additional Information Contact |
Rich Wolyn 201-831-5158
|
Manufacturer Reason for Recall |
A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.
|
FDA Determined Cause 2 |
Process design |
Action |
Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007. |
Quantity in Commerce |
4 units |
Distribution |
Product went to 2 US Stryker branches. |
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.
|
510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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