—#94238

Product

Scorpio/ NRG 4 i n1 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 to align with two previously located holes and for seating on the distal surg ace of the femur, and provide guided slots for the sawblades to make bone cuts.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 8010-0009

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa

Timeline

Recall initiated: 2010-08-23
Posted by FDA: 2010-10-13
Terminated: 2012-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94238. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.