Date Initiated by Firm | August 23, 2010 |
Date Posted | October 13, 2010 |
Recall Status1 |
Terminated 3 on August 30, 2012 |
Recall Number | Z-0050-2011 |
Recall Event ID |
56680 |
Product Classification |
Orthopedics manual surgical instrument - Product Code LXH
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Product | 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. |
Code Information |
8010-0004 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
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For Additional Information Contact | Colleen 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 |
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. |
Quantity in Commerce | 839 (total) |
Distribution | Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa |
Total Product Life Cycle | TPLC Device Report |
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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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