Collagen Matrix, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0414-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 16, 2018

Date Posted: November 21, 2018

Recall Number: Z-0414-2019

Event ID: 81282

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.

Status: Terminated

Product Quantity: 569

Code Information:

CDMEN18F1, CDMEN18F3

Distribution Pattern:

Distributed to one distributor located in Florida.

Voluntary or Mandated:

Voluntary: Firm initiated