Z-0414-2019Class III

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

Name: Z-0414-2019 BioMend Extend, REF# 0142Z, Synthetic bone grafting material
Creator: Collagen Matrix, Inc.
Published: 2018-08-16
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2018-08-16 / Terminated / root cause: manufacturing process

FDA source

Collagen Matrix, Inc. began a recall of BioMend Extend, REF# 0142Z, Synthetic bone grafting material on 2018-08-16. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0414-2019
Classification: Class III
Status: Terminated
Initiated: 2018-08-16
Posted: 2018-11-09
Terminated: 2020-06-23
Recalling firm: Collagen Matrix, Inc
Product: BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Product code: LYC Bone Grafting Material, Synthetic
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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.
Product codes and lots: CDMEN18F1, CDMEN18F3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0414-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0414-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-09

Product code LYC

K062846Class IICollagen Dental Membrane IIICollagen Matrix, Inc. / cleared 2006-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)