AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5"… recallZ-1009-2011 · Covidien LP · initiated Dec 15, 2010
Terminated All recalls posted in February 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility compromised due to breach in sterile barrier
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-1009-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 15, 2010
- Posted by the FDA
- Feb 1, 2011
- Recalling firm
- Covidien LP
- Quantity
- 132 units
- Product code
- FTL
- FDA submissions
- K915526
- 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 description
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.
Code information (models, lots, serial numbers)
Lot Number: A0K0490 Exp Date: 2015-10
Other devices under the same FDA submission
6 devices cleared under K915526 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Surgipro SPM-35Covidien LP · Mesh, surgical, polymeric1 death121 reports
- Surgipro SPM-149Covidien LP · Mesh, surgical, polymeric1 death33 reports
- Surgipro SPMM-149Covidien LP · Mesh, surgical, polymeric18 reports
- Surgipro SPMM-14Covidien LP · Mesh, surgical, polymeric7 reports
- Surgipro SPM-149-WCovidien LP · Mesh, surgical, polymeric6 reports
- Surgipro SPM-14-WCovidien LP · Mesh, surgical, polymeric1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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