Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Midas REx Legend Lubricant Diffuser Cartridge

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medtronic Midas REx Legend Lubricant Diffuser Cartridgesee related information
Date Initiated by FirmNovember 03, 2004
Date PostedNovember 20, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall NumberZ-0213-05
Recall Event ID 30385
510(K)NumberK020069 
Product Classification Motor, Drill, Pneumatic - Product Code HBB
ProductMedtronic 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
FEI Number 1625507
Recalling Firm/
Manufacturer		 Power Surgical Solutions
4620 N Beach St
Fort Worth TX 76137-3219
For Additional Information ContactAmy 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
ActionThe firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.
Quantity in Commerce12,286 cases of 4 units per case
DistributionProduct was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.
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.
510(K) Database510(K)s with Product Code = HBB
-
-