RESODURA matrix onlay 10 — Class II medical device recall Z-0669-2022
Terminated recall by Collagen Matrix, Inc., reported 2022-03-02, distributed nationwide. Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient inf
| Recall number | Z-0669-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Collagen Matrix, Inc., Allendale, NJ, United States |
| Recall initiated | 2021-12-13 |
| Classified | 2022-02-24 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CO, DE |
| Quantity | 10 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00813954023267 |
| Lot numbers | 2107292022 |
| Model numbers | DUMO10125 |
| Expiration dates | 2024-07-31 |
Product
RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Reason for recall
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
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-0669-2022. 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.