FDA Device recall Z-2076-2023
SurgiMend PRS Meshed
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of SurgiMend PRS Meshed 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-2076-2023 |
| 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 PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Reason
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Identifiers
| code_info | Item No. 606-907-001. No UDI-DI (Distributed in Canada and EU). |
|---|
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-2076-2023%22
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