Z-0414-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- August 16, 2018
- Termination Date
- June 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 569
Product Description
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Reason for Recall
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.
Distribution Pattern
Distributed to one distributor located in Florida.
Code Information
CDMEN18F1, CDMEN18F3