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Class 2 Device Recall Stryker Orthopaedics, Duracon XCelerate |
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Date Initiated by Firm |
December 03, 2009 |
Date Posted |
May 10, 2010 |
Recall Status1 |
Terminated 3 on September 14, 2012 |
Recall Number |
Z-1588-2010 |
Recall Event ID |
54083 |
Product Classification |
manual orthopedic surgical instrument - Product Code LXH
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Product |
Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL;
XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile. |
Code Information |
Catalog number: 8000-7050, all lots |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
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For Additional Information Contact |
Colleen O'Meara 201-831-5970
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Manufacturer Reason for Recall |
The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.
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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
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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.
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