PriMatrix Meshed — Class II medical device recall Z-2079-2023
Ongoing recall by TEI Biosciences, Inc., reported 2023-07-12, distributed nationwide. Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxi
| Recall number | Z-2079-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TEI Biosciences, Inc., Boston, MA, United States |
| Recall initiated | 2023-05-23 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 33,277 units |
| Reason classes | sterility, specification failure |
| UPC / GTIN / UDI-DI | 10381780113423, 10381780113430, 10381780113447, 10381780113454, 10381780113461, 10381780113478, 10381780113485 |
| Model numbers | 607-005-225, 607-005-330, 607-005-440, 607-005-550, 607-005-660, 607-005-812, 607-005-880 |
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 for recall
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2079-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.