Recall Z-0414-2019— Collagen Matrix, Inc.

Name: FDA recall Z-0414-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-16

Class III · Terminated

Class III FDA medical device recall by Collagen Matrix, Inc., initiated 2018-08-16, terminated 2020-06-23. It names one FDA 510(k) clearance: K062846. Product: BioMend Extend, REF# 0142Z, Synthetic bone grafting material.. Reason: 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..

Recalling firm: Collagen Matrix, Inc.
Classification: Class III
Status: Terminated
Initiated: 2018-08-16
Terminated: 2020-06-23
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K062846 — COLLAGEN DENTAL MEMBRANE IIICollagen Matrix, Inc.·cleared 2006-10-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.