FDA Medical Device Recalls (openFDA)
Collagen Matrix, Inc.: BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
- Recall number
- Z-0414-2019
- Recalling firm
- Collagen Matrix, Inc.
- Product
- BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
- Status
- Terminated
- Initiated
- 2018-08-16
- Posted
- 2018-11-09
- Terminated
- 2020-06-23
- 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.
- Root 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
- 569
- Distribution
- Distributed to one distributor located in Florida.
- Lot, serial or model codes
- CDMEN18F1, CDMEN18F3
- 510(k) numbers
- ["K062846"]
- PMA numbers
- not on file
- Product code
- LYC
- Firm FEI
- 3003300673
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28