Date Initiated by Firm |
August 11, 2005 |
Date Posted |
October 15, 2005 |
Recall Status1 |
Terminated 3 on August 15, 2007 |
Recall Number |
Z-0059-06 |
Recall Event ID |
33035 |
510(K)Number |
K974556
|
Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
Product |
Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package. |
Code Information |
Catalog No. 70-4107R Lot code: K04W896. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Dominick Cristofolo 201-831-5247
|
Manufacturer Reason for Recall |
The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
|
FDA Determined Cause 2 |
Other |
Action |
The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt. |
Quantity in Commerce |
7 units |
Distribution |
The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France. |
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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