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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 Device Recall ProTack 5mm Single Use Instrument with 30 Helical Fastenerssee related information
Date Initiated by FirmFebruary 08, 2010
Date PostedMarch 16, 2010
Recall Status1 Terminated 3 on February 28, 2013
Recall NumberZ-1157-2010
Recall Event ID 54537
510(K)NumberK090470 K963999 
Product Classification Implantable Staple - Product Code GDW
ProductAuto 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 ContactGarrett Raymond
203-492-5157
Manufacturer Reason
for Recall		Fixation device may fail to fire and staple.
FDA Determined
Cause 2		Process control
ActionCovidien 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 Commerce5,638 units
DistributionNationwide Distribution
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 = GDW
510(K)s with Product Code = GDW
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