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Terminated

Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block ML; XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.

FDA Recall Z-1586-2010 · Posted 2010-05-10

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2009-12-03
Date Terminated2012-09-14
Product Quantity3056 Duracon Cutting Blocks, total

Reason for Recall

The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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