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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Midas REx Legend Lubricant Diffuser Cartridge

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  Class 2 Device Recall Medtronic Midas REx Legend Lubricant Diffuser Cartridge see related information
Date Initiated by Firm November 03, 2004
Date Posted November 20, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-0213-05
Recall Event ID 30385
510(K)Number K020069  
Product Classification Motor, Drill, Pneumatic - Product Code HBB
Product Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
Code Information A5972-V01; A5982-V01; A5991-V01; A5992-V01; A6308-V01through A6327-V01; A6666-V01 through A6684-V01; A6686-V01 through A6691-V01; A6919-V01 through A6934-V01; A7184-V01 through A7188-V01; A7194-V01through A7198-V01; A7495-V01 through A7501-V01; A7520-V01; A7521-V01; and A7525-V01
Recalling Firm/
Manufacturer		 Power Surgical Solutions
4620 N Beach St
Fort Worth TX 76137-3219
For Additional Information Contact Amy Harris
800-443-7080
Manufacturer Reason
for Recall		 Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
FDA Determined
Cause 2		 Other
Action The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.
Quantity in Commerce 12,286 cases of 4 units per case
Distribution Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.
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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