Recall Z-0788-2016 ยท LYC Bone Grafting Material, Synthetic
Biomet France SARL
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 alv
| Date | Feb 9, 2016 (initiated Jan 21, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Zimmer BIOMET France SARL has initiated a voluntary recall via certified mail on January 2, /2016 for the Endobon Xenograft Granules, based on limited (in vitro/bench) results which indicated cytotoxicity tests were not passed at 36 months (real-time) aging. Use of the Endobon Xenograft Granules may result in patient may experiencing soft tissue irritation, up to and including infection. Customers area asked to do the following: 1. Please review this notice. 2. Identify, remove from service and segregate all affected Endobon ROX* product in your inventory. 3. Complete the attached Business |
| Quantity | 145,116 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110449 | ENDOBON XENOGRAFT GRANULES Biomet 3i, May 13, 2011 |