Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block XL; XCelerate cutting block for distal femur in orthopaedic surg
FDA device recall Z-1588-2010 · posted 2010-05-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 3056 Duracon Cutting Blocks, total
- Distribution
- Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.
- Date initiated
- 2009-12-03
- Date posted
- 2010-05-10
- Date terminated
- 2012-09-14
- Location
- Mahwah, NJ
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