Date Initiated by Firm |
April 05, 2010 |
Date Posted |
August 02, 2010 |
Recall Status1 |
Terminated 3 on August 28, 2012 |
Recall Number |
Z-2118-2010 |
Recall Event ID |
55330 |
Product Classification |
knee prosthesis instrument - Product Code LXH
|
Product |
Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.
|
Code Information |
Catalog number 7650-5005. All lots. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact |
Colleen O'Meara 201-831-5970
|
Manufacturer Reason for Recall |
There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part.
|
FDA Determined Cause 2 |
Device Design |
Action |
Stryker Urgent Product Recall letters dated April 8, 2010, were sent by Federal Express to Stryker Branches/agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. |
Quantity in Commerce |
676 in US, 1305 internationally. |
Distribution |
Worldwide distribution. |
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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