Biomet France SARL recalls Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures.…

Recall date

January 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0788-2016

FDA classification

Class II

Brand / firm

Biomet France SARL

Sold / distributed

Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.