Date Initiated by Firm |
February 08, 2005 |
Date Posted |
July 16, 2008 |
Recall Status1 |
Terminated 3 on July 16, 2008 |
Recall Number |
Z-1382-2008 |
Recall Event ID |
47219 |
510(K)Number |
K962152
|
Product Classification |
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis - Product Code JWH
|
Product |
Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430. |
Code Information |
Lot Number: K04W718. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Rita Intorella 201-831-5825
|
Manufacturer Reason for Recall |
Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825. |
Quantity in Commerce |
5 units |
Distribution |
Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK. |
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 = OSTEONICS CORP.
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