The Recall Desk
LowFDA (Devices)·Z-0414-2019·Announced 2018-11-21

Collagen Matrix Recalls BioMend Extend Due to Potential Packaging Error

Collagen Matrix, Inc. is recalling 569 units of BioMend Extend synthetic bone grafting material because the product may have been packaged in the wrong box.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging error where the product is in the wrong box, but the internal labels and instructions are correct.

Plain-English summary

Collagen Matrix, Inc. is recalling 569 units of BioMend Extend, REF# 0142Z, a synthetic bone grafting material. The recall was initiated because 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, and the Instructions for Use inside the box are also correct. The affected lots are identified by codes CDMEN18F1 and CDMEN18F3.

The product was distributed to one distributor located in Florida. Consumers and healthcare providers should check their inventory for these specific lot codes and contact the manufacturer for further instructions.

The recalled product

Product
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Affected units
569

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • CDMEN18F1
  • CDMEN18F3

Distribution

Distributed in 1 state: