Recall Z-0892-05 ยท FTM Mesh, Surgical
Synovis Surgical Inovation Div. of
Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovatio
| Date | Jun 14, 2005 (initiated May 23, 2005) |
| Status | Terminated |
| Reason | Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile. |
| Root cause | Other |
| Action | The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return. |
| Quantity | 56 boxes each box containing 6 pouches |
| Distribution | AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.