Class III — 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 III |
| Status | Terminated |
| Reason | There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct. |
| Product | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. |
| Quantity | 569 |
| Distribution | Distributed to one distributor located in Florida. |
| Initiated | 2018-08-16 |
| Classified | 2018-11-09 |
| Terminated | 2020-06-23 |
| Recall number | Z-0414-2019 |
| 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 III recall — Collagen Matrix, Inc. (Z-0414-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81282/
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