Z-1157-2010

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

Name: Z-1157-2010 Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures
Creator: Covidien LP
Published: 2010-02-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-02-08 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures on 2010-02-08. The reason FDA records is "Fixation device may fail to fire and staple". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1157-2010
Status: Terminated
Initiated: 2010-02-08
Posted: 2010-03-16
Terminated: 2013-02-28
Recalling firm: Medtronic, Inc.
Product: Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
Product code: GDW Staple, Implantable
Reason for recall: Fixation device may fail to fire and staple.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Batch Number: P9M0113, P9M0312, P9M0515, P9M0516, P9M0647, P9M0696, P9M0771, P9M0816. Expanded Recall 6/23/10: P9H1081, P9M0113, P0A0021,P0A0723, P0B0753

Product code GDW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)