FDA Device recall Z-2072-2023
SurgiMend 2.0
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of SurgiMend 2.0 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-2072-2023 |
| 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 2.0; 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, 20x25cm, 10x15cm Semi-Oval,
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): 606-200-002 (10381780112976), 606-200-004 (10381780112983), 606-200-006 (10381780112990), 606-200-00…Item No. (UDI-DI): 606-200-002 (10381780112976), 606-200-004 (10381780112983), 606-200-006 (10381780112990), 606-200-008 (10381780113003), 606-200-009 (10381780113010), 606-200-016 (10381780113027), 606-200-017 (10381780113034), 606-200-019 (10381780113041), 606-200-020 (10381780113058), and 606-204-100 (10381780113065). |
|---|
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-2072-2023%22
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