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 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 Recall Z-0049-2011 · Posted 2010-10-13
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-08-23
Date Terminated2012-08-30
Product Quantity839 (total)
Reason for Recall
Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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