Recall Z-0807-2021 ยท FTM Mesh, Surgical
Baxter Healthcare Corporation
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
| Date | Dec 11, 2020 |
| Status | Terminated |
| Reason | VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. |
| Root cause | Process design |
| Action | An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail. |
| Quantity | 192 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of FL, IL, MA, MS, OH, OR, TX, VA, WA, WV and the countries of Australia, Poland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062915 | VERITAS COLLAGEN MATRIX Synovis Surgical Innovations, Dec 6, 2006 |