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

• Date Initiated by Firm: April 05, 2010
• Date Posted: August 02, 2010
• Recall Status: Terminated 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: 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.