Collagen Matrix, Inc. recalls BioMend Extend, REF# 0142Z, Synthetic bone grafting material.

Recall date

August 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0414-2019

FDA classification

Class III

Brand / firm

Collagen Matrix, Inc.

Sold / distributed

Distributed to one distributor located in Florida.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

BioMend Extend, REF# 0142Z, Synthetic bone grafting material.