Reported Nov 21, 2018 · Terminated

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

Collagen Matrix, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Collagen Matrix, Inc. · 110 Commerce Dr · Allendale, NJ · 07401-1622

Is this the product you have?

  • BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Lot codes and dates
    • CDMEN18F1
    • CDMEN18F3
Amount recalled
569

Where it was sold

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 23, 2020 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.