FDA Device recall Z-2073-2023
SurgiMend MP
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of SurgiMend MP 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-2073-2023 |
| 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 MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 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): 606-206-001 (10381780357339), 606-206-002 (10381780357360), 606-206-003 (10381780357346), 606-206-00…Item No. (UDI-DI): 606-206-001 (10381780357339), 606-206-002 (10381780357360), 606-206-003 (10381780357346), 606-206-004 (10381780357353), 606-206-005 (10381780357377), 606-206-006 (10381780357384), and 606-206-007 (10381780357391). |
|---|
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-2073-2023%22
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