Reported Feb 17, 2016 · Terminated
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures.…
Biomet France SARL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet France SARL · Plateau de Lautagne · Valence Cedex 9, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Item Numbers &Lot Numbers
756 of 756 codes
ROX05S016303ROX05S016304ROX05S0163056ROX05S0163059ROX05S0171051ROX05S017105RROX05S0171098ROX05T0001122ROX05T0001133ROX05T0001136ROX05T0001141ROX05T0001147ROX05T0025073ROX05T0034084ROX05T0045150ROX05T0045157ROX05T0052108ROX05T0064164ROX05T0064168ROX05T0064175ROX05T0096191ROX05T0104217ROX05T0104238ROX05T0114238ROX05T0122226ROX05T0122238ROX05T0134261ROX05T0134269ROX05T0142245ROX05T0142248
- Item Numbers &Lot Numbers
- Amount recalled
- 145,116 units
Where it was sold
Why it 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.
This product could cause temporary or reversible health problems — stop using it.
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