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 ProTack 5mm Single Use Instrument with 30 Helical Fasteners

  • 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 ProTack 5mm Single Use Instrument with 30 Helical Fasteners see related information
Date Initiated by Firm February 08, 2010
Date Posted March 16, 2010
Recall Status1 Terminated 3 on February 28, 2013
Recall Number Z-1157-2010
Recall Event ID 54537
510(K)Number K963999  K090470  
Product Classification Implantable Staple - Product Code GDW
Product Auto Suture ProTack Fixation 5 mm
Product Catalogue # 174006.

Has application in endoscopic surgery procedures.
Code Information Batch Number: P9M0113, P9M0312, P9M0515, P9M0516, P9M0647, P9M0696, P9M0771,  P9M0816. Expanded Recall 6/23/10: P9H1081, P9M0113, P0A0021,P0A0723, P0B0753
Recalling Firm/
Manufacturer		 Covidien LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Garrett Raymond
203-492-5157
Manufacturer Reason
for Recall		 Fixation device may fail to fire and staple.
FDA Determined
Cause 2		 Process control
Action Covidien notified accounts by "Urgent Medical Device Recall" letters dated 2/8/10. The letter identified the affected product and the reason for recall. Customers are to examine their inventory, and remove and return recalled lots. Customers are to follow the instructions provided in the letter to return the affected product. Questions should be directed to a Covidien Representative. On June 23, 2010, the firm issued a letter to expand the recall to include 5 additional lots.
Quantity in Commerce 5,638 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 = GDW and Original Applicant = COVIDIEN
510(K)s with Product Code = GDW and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
-
-