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U.S. Department of Health and Human Services

Class 2 Device Recall ProTack 5mm Single Use Instrument with 30 Helical Fasteners

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 Class 2 Recall
ProTack 5mm Single Use Instrument with 30 Helical Fasteners
see related information
Date Posted March 16, 2010
Recall Status1 Terminated on February 28, 2013
Recall Number Z-1157-2010
Recall Event ID 54537
Premarket Notification
510(K) Numbers
K090470  K963999 
Product Classification Staple, Implantable - 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/
Covidien LP
60 Middletown Ave
North Haven, Connecticut 06473-3908
For Additional Information Contact Garrett Raymond
Manufacturer Reason
for Recall
Fixation device may fail to fire and staple.
FDA Determined
Cause 2
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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