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

Recall Z-0119-2013 — Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing

U.S. FDA — Device Enforcement · United States · 2012-08-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0119-2013
Date of alert: 2012-08-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet 3i, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 2011090751

Reported risk: Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.

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.

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