Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0788-2016 — 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 el

U.S. FDA — Device Enforcement · France · 2016-01-21 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0788-2016
Date of alert: 2016-01-21
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: Biomet France SARL
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related