# FDA recall Z-0414-2019

> **Collagen Matrix, Inc.** · Class III · device recall initiated 2018-08-16.

## 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.

## Distribution

Distributed to one distributor located in Florida.

## Key facts

- **Recall number:** Z-0414-2019
- **Recalling firm:** Collagen Matrix, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-16
- **Report date:** 2018-11-21
- **Termination date:** 2020-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allendale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2019

## Citation

> AI Analytics. FDA recall Z-0414-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0414-2019. Source: US FDA. Licensed CC0.

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