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Class 2 Device Recall ProTack 5mm Single Use Instrument with 30 Helical Fasteners |
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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
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Product Classification |
Implantable Staple - Product Code GDW
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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
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For Additional Information Contact |
Garrett Raymond 203-492-5157
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Manufacturer Reason for Recall |
Fixation device may fail to fire and staple.
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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
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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.
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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
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