Class II — Collagen Matrix, Inc.
| Recalling firm | COLLAGEN MATRIX, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| Product | DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45 |
| Quantity | 68 units |
| Distribution | DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany. |
| Initiated | 2021-12-13 |
| Classified | 2022-02-24 |
| Terminated | 2024-09-18 |
| Recall number | Z-0668-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Collagen Matrix, Inc. (Z-0668-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89495/
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