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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics, Duracon XCelerate

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  Class 2 Device Recall Stryker Orthopaedics, Duracon XCelerate see related information
Date Initiated by Firm December 03, 2009
Date Posted May 10, 2010
Recall Status1 Terminated 3 on September 14, 2012
Recall Number Z-1585-2010
Recall Event ID 54083
Product Classification manual orthopedic surgical instrument - Product Code LXH
Product Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block MED;

XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
Code Information Catalog number: 8000-7020, all lots.
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
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 2
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.