FDA-Device2018-11-21Class III
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Collagen Matrix, Inc.
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.
Sold states
Distributed to one distributor located in Florida.
Affected count
569
Manufactured in
110 Commerce Dr, Allendale, NJ, United States
Products
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2019Don't want to check this manually?
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