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Recall Observatory FDA recall evidence

Device product

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

Z-0414-2019

August 16, 2018

Class III

Product summary

Firm
Collagen Matrix, Inc.
Event
Event 81282
Status
Terminated
Classification
Class III
Quantity
569
Official record key
device-enforcement:Z-0414-2019

Official wording

Reason: 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.

Code information: CDMEN18F1, CDMEN18F3

Distribution pattern: Distributed to one distributor located in Florida.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.