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U.S. Department of Health and Human Services

Class 2 Device Recall Passport A.R. Knee Instrumentation Distal Guide Stand

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  Class 2 Device Recall Passport A.R. Knee Instrumentation Distal Guide Stand see related information
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
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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