Endobon-Xenograft Granules — Class II medical device recall Z-0788-2016
Terminated recall by Biomet France SARL, reported 2016-02-17, distributed in AK, AL, AR, CA, CO, CT, DC, DE…. Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its speci
| Recall number | Z-0788-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet France SARL, Valence Cedex 9, N/A, France |
| Recall initiated | 2016-01-21 |
| Classified | 2016-02-09 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2017-05-31 |
| Distributed | AK, AL, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | CA, JP |
| Quantity | 145,116 units |
| Lot numbers | ROX05, ROX10, ROX20, ROXLG20, ROXLG50, ROXLG80, S016303, S016304, S0163056, S0163059, S0171051, S0171056, S017105R, S0171065, S0171098, S0171108, S017204, T0001119, T0001122, T0001133, T0001136, T0001141, T0001147, T0001150, T0002136, T0002141, T0002150, T0002157, T0002164, T0025073, T0025098, T0026056, T0034084, T0035065, T0035073, T0035084, T0035098, T0044175, T0044179, T0044189 and 227 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0788-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.