Zimmer Biomet Recalls Endobon Xenograft Granules Due to Cytotoxicity Failure
Biomet France SARL is recalling Endobon-Xenograft Granules because the product failed cytotoxicity tests at 36 months. Use past the 18-month shelf life may cause patient illness or injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that use past the shelf life 'may result in patient illness/injury,' which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet France SARL is recalling 145,116 units of Endobon-Xenograft Granules, a synthetic bone grafting material manufactured by Zimmer Biomet. The product is used in various dental and surgical procedures, including alveolar ridge augmentation, sinus elevation, and filling of bone defects.
The recall was initiated because the product failed cytotoxicity tests at 36 months. The source text states that using Endobon-Xenograft Granules past its specified 18-month shelf life may result in patient illness or injury. The affected units were distributed worldwide, including across the United States and internationally to Canada, Japan, and Europe.
Consumers and healthcare providers should stop using the affected lots immediately. The recall covers specific item and lot numbers, which are listed in the official FDA recall record Z-0788-2016. Users should check their inventory against the provided list of affected lot numbers to determine if they possess the recalled product.
The recalled product
- 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/recons
- Manufacturer
- Biomet France SARL
- Affected units
- 145,116
Distribution
Related recalls
Same hazard · cytotoxicity
See all →- ModerateMulti-Snare Set catheter fails biocompatibility requirements
FDA (Devices) · 2026-07-01
- HighBayonet injection needles recalled after showing elevated cytotoxicity in testing
FDA (Devices) · 2025-08-27
- HighYukon Straight Rod spinal implants recalled for discoloration and contamination
FDA (Devices) · 2022-07-06
- HighEBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity
FDA (Devices) · 2017-05-31
- HighEBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity
FDA (Devices) · 2017-05-31