Recall Z-1009-2011 ยท FTL Mesh, Surgical, Polymeric
Covidien LP
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
| Date | Feb 1, 2011 (initiated Dec 15, 2010) |
| Status | Terminated |
| Reason | Sterility compromised due to breach in sterile barrier |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915526 | COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH United States Surgical, A Division of Tyco Healthc, May 29, 1992 |