BioMend Extend, REF# 0142Z, Synthetic bone grafting material.

FDA device recall Z-0414-2019 · posted 2018-11-09 · Terminated

Recall details

Recalling firm

Collagen Matrix, Inc.

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.

Action taken

On August 16, 2018, Zimmer Biomet Dental issued Urgent Medical Device Recall Notices to affected customers. The letter described the issue and specified that there was no projected risk to patient health. CLINICIAN RESPONSIBILITIES: Complete the attached Certificate of Acknowledgement within 15 days of receipt and email the completed form to postmarket@zimmerbiomet.com or return the form to: Product Recall Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 If any of the items noted in the scope of this letter remain in your possession, please return them along with a copy of the form to the address shown above. Replacement product will be provided upon receipt of the return. If you have any questions after reviewing this notice, please call 800-342-5454 between 8:00 am and 5:00 pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail.

Root cause

Employee error

Status

Terminated

Product code

LYC

Quantity affected

569

Distribution

Distributed to one distributor located in Florida.

Date initiated

2018-08-16

Date posted

2018-11-09

Date terminated

2020-06-23

Location

Allendale, NJ

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