Recall Z-2074-2023 ยท FTM Mesh, Surgical
TEI Biosciences, Inc.
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
| Date | Sep 30, 2024 (initiated May 23, 2023) |
| Status | Open, Classified |
| Reason | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| Root cause | Under Investigation by firm |
| Action | The firm sent recall notifications to customers via email on 5/23/2023 and by mail on 5/24/2023. The recall notification informs customers that Integra is conducting a removal of all Surgimend PRS, Surgimend PRS Meshed, Surgimend, Surgimend MP, Revize, Revize-X, PriMatrix Dermal Repair Scaffold, and PriMatrix AG Antimicrobial Dermal Repair Scaffold devices due to identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results. Customers are to check their stock for any lot of products listed in the provided Appendix and immediate |
| Quantity | 13,390 units |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083898 | SURGIMEND Tei Biosciences, Inc., Feb 4, 2009 |