—#87412

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog anumber: 8000-7010, all lots.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

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

Timeline

Recall initiated: 2009-12-03
Posted by FDA: 2010-05-10
Terminated: 2012-09-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87412. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.