Class 3 Device Recall BioMend Extend Absorbable Collagen Membrane

• Date Initiated by Firm: August 16, 2018
• Date Posted: November 09, 2018
• Recall Status: Terminated on June 23, 2020
• Recall Number: Z-0414-2019
• Recall Event ID: 81282
• 510(K)Number: K062846
• Product Classification: Bone grafting material, synthetic - Product Code LYC
• Product: BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
• Code Information: CDMEN18F1, CDMEN18F3
• FEI Number: 3003300673
• Recalling Firm/ Manufacturer: Collagen Matrix, Inc.; 110 Commerce Dr; Allendale NJ 07401-1622
• For Additional Information Contact: Customer Service; 800-342-5454
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: 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.
• Quantity in Commerce: 569
• Distribution: Distributed to one distributor located in Florida.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LYC