BioMend Extend — Class III medical device recall Z-0414-2019
Terminated recall by Collagen Matrix, Inc., reported 2018-11-21, distributed in FL. There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been
| Recall number | Z-0414-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Collagen Matrix, Inc., Allendale, NJ, United States |
| Recall initiated | 2018-08-16 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-06-23 |
| Distributed | FL |
| Quantity | 569 |
| Reason classes | labeling |
| Model numbers | 0142Z |
Product
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Reason for recall
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.
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-0414-2019. 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.