FDA Device

Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile

Hazard

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

What You Should Do

Remedy

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.

Products

Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3; XCelerate cutting block for distal femur in orthopaedic surgery, Non Sterile
Brand
Stryker Howmedica Osteonics Corp.
UPC
Catalog number: 8000-0003, all lots.

Units Affected

9833 Scorpio Cutting Blocks, total.