Z-1009-2011

AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a...

Name: Z-1009-2011 AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a...
Creator: Covidien LP
Published: 2010-12-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-12-15 / Terminated / root cause: packaging

FDA source

Covidien LP began a recall of AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting... on 2010-12-15. The reason FDA records is "Sterility compromised due to breach in sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1009-2011
Status: Terminated
Initiated: 2010-12-15
Posted: 2011-02-01
Terminated: 2013-01-10
Recalling firm: Medtronic, Inc.
Product: AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength. Surgipro comes in multiple designs, including multi-filament and open weave. All designs are knitted in such a fashion as to provide bi-directional elasticity, while allowing the mesh to be cut to any shape without unraveling. Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a non-absorbable mesh during and after wound healing.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Sterility compromised due to breach in sterile barrier
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Covidien notified customers via letter dated November 15, 2010. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to examine inventory and return the affected lot to Field Returns Department, 195 McDermott Road, North Haven, CT 06473. For questions regarding this recall call 203-492-8091.
Quantity in commerce: 132 units
Distribution: Worldwide Distribution - USA including CA, CT, FL, HI, IL, IN, KS, MA, MD, MI, MN, NC, NJ, NY, OH, PA, SC, TX, and WI and the countries of Canada and Italy
Product codes and lots: Lot Number: A0K0490 Exp Date: 2015-10

Product code FTL

K915526Class IICoated Surgipro(tm) Polypropylene Surgical MeshUnited States Surgical, A Division of Tyco Healthc / cleared 1992-05-29

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)