Recall Z-0274-2012 ยท FTM Mesh, Surgical
Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024. The device is intended to be used as a staple line buttress
| Date | Nov 23, 2011 (initiated Oct 26, 2011) |
| Status | Terminated |
| Reason | Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled. |
| Root cause | Labeling mix-ups |
| Action | Synovis Surgical Inovation sent a "Recall Notification" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form. |
| Quantity | 132 units |
| Distribution | Nationwide Distribution including CT, GA, NJ, NY, OH, TX, 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 |