FDA Device

Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for seating the femoral component (implant) in place. The Scorpio Cutting blocks (8010-00xx) are designed

Hazard

Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery.

What You Should Do

Remedy

Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated August 30, 2010, to all consignees/customers (branches/agencies, hospital risk management, hospital Chief of Orthopaedics, surgery) including foreign countries. The letter described the product, problem, and action to be taken by customers. The customers were instructed to complete and return the attached PRODUCT RECALL ACKNOWLEDGMENT FORM via fax to 201-831-6069. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance (201) 972-2100.

Products

Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cu
Brand
Stryker Howmedica Osteonics Corp.
UPC
8010-0003

Units Affected

839 (total)