Date Initiated by Firm |
March 17, 2005 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on September 24, 2008 |
Recall Number |
Z-2079-2008 |
Recall Event ID |
48199 |
510(K)Number |
K962152
|
Product Classification |
Patellofemorotibial knee prosthesis - Product Code JWH
|
Product |
Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components. |
Code Information |
Catalog No. 711-4513L; Lot Code: K04S174 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Colleen O'Meara 201-831-5000
|
Manufacturer Reason for Recall |
Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
|
FDA Determined Cause 2 |
Process control |
Action |
The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005 |
Quantity in Commerce |
1 unit |
Distribution |
The one unit was distributed to an International Stryker branch. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|