FDA Device recall Z-2079-2023
PriMatrix Meshed
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of PriMatrix 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-2079-2023 |
| 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
PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
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): 607-005-225 (10381780113423), 607-005-330 (10381780113430), 607-005-440 (10381780113447), 607-005-55…Item No. (UDI-DI): 607-005-225 (10381780113423), 607-005-330 (10381780113430), 607-005-440 (10381780113447), 607-005-550 (10381780113454), 607-005-660 (10381780113461), 607-005-812 (10381780113478), 607-005-880 (10381780113485). |
|---|
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-2079-2023%22
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