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U.S. Department of Health and Human Services

Class 2 Device Recall Midas Rex Legend dissecting tool

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  Class 2 Device Recall Midas Rex Legend dissecting tool see related information
Date Initiated by Firm May 30, 2008
Date Posted August 23, 2008
Recall Status1 Terminated 3 on August 22, 2009
Recall Number Z-2156-2008
Recall Event ID 48472
510(K)Number K020069  
Product Classification Pneumatic drill motor - Product Code HBB
Product Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23
Medtronic Powered Surgical Solutions, Forth Worth, TX

Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.
Code Information Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288
Recalling Firm/
Manufacturer		 Medtronic Powered Surgical Solutions
4620 N Beach St
Fort Worth TX 76137-3219
For Additional Information Contact
817-831-4181
Manufacturer Reason
for Recall		 Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
FDA Determined
Cause 2		 Process control
Action Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.
Quantity in Commerce 1,306 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = HBB and Original Applicant = MEDTRONIC MIDAS REX
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