Recall Z-0764-06 ยท FTM Mesh, Surgical
Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 2575 University Ave. W., St. Paul, MN 55114-1024 USA.
| Date | Apr 13, 2006 (initiated Nov 1, 2005) |
| Status | Terminated |
| Reason | The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable. |
| Root cause | Other |
| Action | An initial phone call was placed to expedite return and replacement of product. A follow-up letter was sent. The initial phone calls to customers began on November 1, 2005. |
| Quantity | 4,950 |
| Distribution | Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD Synovis Surgical Innovations, Oct 27, 2004 |