Class 2 Device Recall Stryker Orthopaedics, Duracon XCelerate

• Date Initiated by Firm: December 03, 2009
• Date Posted: May 10, 2010
• Recall Status: Terminated on September 14, 2012
• Recall Number: Z-1583-2010
• Recall Event ID: 54083
• Product Classification: manual orthopedic surgical instrument - Product Code LXH
• Product: Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XS;; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
• Code Information: Catalog Number: 8000-7005, 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: The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.
• FDA Determined Cause: Device Design
• Action: Urgent Product Recall Letters were sent on December 3, 2009 via Federal Express to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. Foreign accounts were notitied on December 7, 2009. Questions or comments should be addressed to Colleen O'Meara at 201-972-2100.
• Quantity in Commerce: 3056 Duracon Cutting Blocks, total
• Distribution: Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.
• 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.