Recall Z-2069-2023 ยท FTM Mesh, Surgical
TEI Biosciences, Inc.
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
| 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 | 14,535 units |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071807 | ORTHOMEND SOFT TISSUE MATRIX Tei Biosciences, Inc., Aug 6, 2007 |