FDA Device recall Z-2069-2023
SurgiMend
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of SurgiMend by Tei Biosciences, citing possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2069-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-23 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tei Biosciences |
| Distribution | US |
Product
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.
Reason
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Identifiers
| code_info | Item No. (UDI-DI): 606-001-002 (10381780112617), 606-001-004 (10381780112624), 606-001-005 (10381780112631), 606-001-00…Item No. (UDI-DI): 606-001-002 (10381780112617), 606-001-004 (10381780112624), 606-001-005 (10381780112631), 606-001-006 (10381780112648), 606-001-007 (10381780112655), 606-001-008 (10381780112662), 606-001-009 (10381780112679), 606-001-010 (10381780112686), 606-001-012 (10381780112693), 606-001-013 (10381780112709), 606-001-014 (10381780112716), 606-001-015 (10381780112723), 606-001-016 (10381780112730), 606-001-017 (10381780112747), 606-001-018 (10381780112754), 606-002-002 (10381780112761), 606-002-003 (10381780112778), 606-002-005 (10381780112785), 606-003-001 (10381780112792), 606-003-002 (10381780112808), 606-003-003 (10381780112815). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2023%22
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