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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio/ NRG 4in1 Cutting Block

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 Class 2 Device Recall Scorpio/ NRG 4in1 Cutting Blocksee related information
Date Initiated by FirmAugust 23, 2010
Date PostedOctober 13, 2010
Recall Status1 Terminated 3 on August 30, 2012
Recall NumberZ-0049-2011
Recall Event ID 56680
Product Classification Orthopedics manual surgical instrument - Product Code LXH
ProductScorpio/ 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.
Code Information 8010-0003
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information ContactColleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery.
FDA Determined
Cause 2		Device Design
ActionStryker 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.
Quantity in Commerce839 (total)
DistributionWorldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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