Recall Z-2078-2023 ยท KGN Wound Dressing With Animal-Derived Material(S)
TEI Biosciences, Inc.
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
| 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 | 30,528 units |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153690 | PriMatrix Dermal Repair Scaffold Tei Biosciences, Inc., Feb 22, 2016 |