FDA Device recall Z-0414-2019
BioMend Extend, REF# 0142Z, Synthetic bone grafting material
- FDA Device
- Class III
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class III recall of BioMend Extend, REF# 0142Z, Synthetic bone grafting material by Collagen Matrix, citing 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 onl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0414-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-16 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Collagen Matrix |
| Distribution | FL |
Product
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
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.
Identifiers
| code_info | CDMEN18F1, CDMEN18F3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.