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 3 Device Recall Medtronic Midas Rex Legacy

  • 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 3 Device Recall Medtronic Midas Rex Legacysee related information
Date Initiated by FirmJanuary 03, 2005
Date PostedJanuary 27, 2005
Recall Status1 Terminated 3 on November 03, 2005
Recall NumberZ-0441-05
Recall Event ID 30904
510(K)NumberK953433 
Product Classification Motor, Surgical Instrument, Pneumatic Powered - Product Code GET
ProductMedtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas 76137
Code Information Lot Number 7087E
Recalling Firm/
Manufacturer		 Power Surgical Solutions
4620 N Beach St
Fort Worth TX 76137-3219
Manufacturer Reason
for Recall		Device is missing the sub-collet component within the dissecting tool package.
FDA Determined
Cause 2		Other
ActionThe firm initiated the recall by letter on 01/03/2005. Firm representative will remove recalled product and replace with new product.
Quantity in Commerce22 tools
DistributionProduct was distributed to three consignees in CA.
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 = GET
-
-