Recall Z-1985-2025 ยท FTL Mesh, Surgical, Polymeric
Chamberlain Technologies LLC
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
| Date | Jun 17, 2025 (initiated Aug 12, 2022) |
| Status | Completed |
| Reason | Potential presence of residual adhesive material on the mesh surface. |
| Root cause | Process control |
| Action | Customer notification began 8/12/22. Initial communication was made directly (by phone and in-person visit). This communication instructed users to segregate and return the affected product to BG Medical. If you have any questions, call 8473044069 or email: d.howard@surgimesh.com. |
| Quantity | 10 units |
| Distribution | US distribution to states of: Illinois, Nebraska, & California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072974 | SURGIMESH XB Aspide Medical, Aug 18, 2008 |