FDA recall Z-0414-2019

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

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

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