{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Valence Cedex 9", "state": "N/A", "country": "France", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "73141", "recalling_firm": "Biomet France SARL", "address_1": "Plateau de Lautagne", "address_2": "N/A", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "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.", "recall_number": "Z-0788-2016", "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.", "product_quantity": "145,116 units", "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.", "recall_initiation_date": "20160121", "center_classification_date": "20160209", "termination_date": "20170531", "report_date": "20160217", "code_info": "Item Numbers &Lot Numbers: ROX05 S016303 ROX05 S016304 ROX05 S0163056 ROX05 S0163059 ROX05 S0171051 ROX05 S017105R ROX05 S0171098 ROX05 T0001122 ROX05 T0001133 ROX05 T0001136 ROX05 T0001141 ROX05 T0001147 ROX05 T0025073 ROX05 T0034084 ROX05 T0045150 ROX05 T0045157 ROX05 T0052108 ROX05 T0064164 ROX05 T0064168 ROX05 T0064175 ROX05 T0096191 ROX05 T0104217 ROX05 T0104238 ROX05 T0114238 ROX05 T0122226 ROX05 T0122238 ROX05 T0134261 ROX05 T0134269 ROX05 T0142245 ROX05 T0142248 ROX05 T0162294 ROX05 T0183280 ROX05 T0192311 ROX05 T0192316 ROX05 T0205297 ROX05 T0214319 ROX05 T0224329 ROX05 T0224333 ROX05 T0224338 ROX05 T0224346 ROX05 T0224357 ROX05 T0234357 ROX05 T0245006 ROX05 T0245009 ROX05 T0254015 ROX05 T0266030 ROX05 T0273037 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U0224026 ROXLG80 U0233047 ROXLG80 U0243040 ROXLG80 U0254061 ROXLG80 U0262075 ROXLG80 V0022082 ROXLG80 V0035097 ROXLG80 V0045120 ROXLG80 V0052117 ROXLG80 V0073176 ROXLG80 V0083141 ROXLG80 V0091159 ROXLG80 V0112194 ROXLG80 V0134208 ROXLG80 V0143230 ROXLG80 V0161208", "more_code_info": "" } ] }