FDAAugust 16, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

collagen matrixcollagen

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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