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
CDMEN18F1CDMEN18F3
- 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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