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Terminated

Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.

FDA Recall Z-1157-2010 · Posted 2010-03-16

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeGDW
Date Initiated2010-02-08
Date Terminated2013-02-28
Product Quantity5,638 units

Reason for Recall

Fixation device may fail to fire and staple.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090470AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICESCovidien · 2009-05-14K963999AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICEUnited States Surgical, A Division of Tyco Healthc · 1996-11-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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