Home / Recalls / Medical Devices
Collagen Matrix, Inc. recalls BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Recalled November 21, 2018 · FDA recall Z-0414-2019 · Collagen Matrix
Hazard
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. · FDA Class III
Units
569
Sold at
Distributed to one distributor located in Florida.
Description
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.
Product
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Manufacturer(s)
Collagen Matrix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →