Collagen Matrix recalls BioMend Extend synthetic bone graft material due to possible wrong box packaging. The product may be placed inside a BioMend box instead of BioMend Extend box, but labels and instructions are correct.
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.
Collagen Matrix is recalling BioMend Extend synthetic bone graft material because it might be packaged in the wrong box. This could cause confusion but does not affect the product's safety or instructions.
The product might be placed inside a BioMend box instead of a BioMend Extend box. This difference is only in the product trade name, but the labels and instructions inside the box remain correct. The hazard is purely about packaging confusion, not product safety.
Patients using BioMend Extend for bone grafting procedures may be affected if they receive the wrong box. Medical professionals handling the product are most at risk of confusion.
Check the box label for the product trade name. The correct BioMend Extend box should have the trade name 'BioMend Extend' on it. The product was sold with reference numbers CDMEN18F1 and CDMEN18F3.
Look for the product trade name on the box to confirm it's BioMend Extend, not BioMend.
Yes, the product is safe to use. The labels and instructions inside the box are correct, so the hazard is only about packaging confusion.
Check the box label for the product trade name. If it says 'BioMend Extend', it's the correct product. If it says 'BioMend', it's the wrong box.
No fix is needed. The hazard is only about packaging confusion, and the product remains safe to use.
We’ve drafted a message you can send Collagen Matrix to request your refund or repair — edit it as you like.
Subject: Recall Z-0414-2019 — Collagen Matrix Collagen Matrix Hello, I own a Collagen Matrix that is covered by recall Z-0414-2019 from Collagen Matrix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
