FDA Device recall Z-0788-2016
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures by Biomet France Sarl, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0788-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-21 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet France Sarl |
| Distribution | 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 |
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.
Identifiers
| code_info | Item Numbers &Lot Numbers: ROX05 S016303 ROX05 S016304 ROX05 S0163056 ROX05 S0163059 ROX05 S0171051 ROX05 S017105…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 ROX05 T0273051 ROX05 T0281043 ROX05 T0281065 ROX05 T0281078 ROX05 T0291099 ROX05 T0291106 ROX05 T0291118 ROX05 T0291125 ROX05 T0291134 ROX05 U0013175 ROX05 U0025142 ROX05 U0025170 ROX05 U0035175 ROX05 U0055155 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0788-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.