Recall Z-0788-2016— Biomet France SARL

Name: FDA recall Z-0788-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-21

Class II · Terminated

Class II FDA medical device recall by Biomet France SARL, initiated 2016-01-21, terminated 2017-05-31. It names one FDA 510(k) clearance: K110449. Product: Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.. Reason: Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury..

Recalling firm: Biomet France SARL
Classification: Class II
Status: Terminated
Initiated: 2016-01-21
Terminated: 2017-05-31
Firm location: Valence Cedex 9, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K110449 — ENDOBON XENOGRAFT GRANULESBiomet 3i·cleared 2011-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.

Reason for recall

Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.