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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 Recall
Passport A.R. Knee Instrumentation Distal Guide Stand
see related information
Date Posted August 02, 2010
Recall Status1 Terminated on August 28, 2012
Recall Number Z-2118-2010
Recall Event ID 55330
Product Classification Orthopedic Manual Surgical 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/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.