Recall record at a glance
| Official record | Z-0788-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Biomet France SARL |
| Report date | Feb 17, 2016 |
| Recall initiation date | Jan 21, 2016 |
| Quantity | 145,116 units |
| Location | Valence Cedex 9, N/A, France |
Official 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.
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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