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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Biomet France SARL
- Affected units
- 145,116
Distribution
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