Recall Z-0414-2019 ยท LYC Bone Grafting Material, Synthetic
Collagen Matrix, Inc.
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
| Date | Nov 9, 2018 (initiated Aug 16, 2018) |
| Status | Terminated |
| 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 |
| Quantity | 569 |
| Distribution | Distributed to one distributor located in Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062846 | COLLAGEN DENTAL MEMBRANE III Collagen Matrix, Inc., Oct 13, 2006 |