BioMend Extend recall
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Why was BioMend Extend 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
CDMEN18F1, CDMEN18F3
- Product
- BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
- Recalling firm
- Collagen Matrix, Inc.
- Quantity
- 569
- Distribution
- Distributed to one distributor located in Florida.
- Recall date
- November 21, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)