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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics Passport A.R. Knee Instrumentation

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 Class 2 Recall
Stryker Orthopaedics Passport A.R. Knee Instrumentation
see related information
Date Posted August 02, 2010
Recall Status1 Terminated on August 28, 2012
Recall Number Z-2120-2010
Recall Event ID 55367
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Howmedica Osteonics Corp., Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide; Catalog Number 7650-5003.
Code Information Catalog Number 7650-5003; all lots.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
One of the two posts on the Anterior Resection Guide could disassociate from the main body of the part which has been determined to be caused by a fracture weld.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker Urgent Product Recall letters dated April 5, 2010, were sent out via Federal Express to Stryker branches/agencies, Hospital Risk Management, hospital Chief of Orthopedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified. Questions and/or concerns should be directed to Rich Wolyn at 201-972-2100.
Quantity in Commerce 682 units in US, 1292 units internationally.
Distribution Worldwide distribution: USA, Ireland, Germany, Sweden, The Netherlands, France, Italy, Switzerland, South Africa, United Kingdom, Japan, Argentina, Mexico, Miramar (city), China, Taiwan, India, Australia, Korea, New Zealand, Malaysia, Singapore, and Canada.
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.
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