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

Recall Z-0298-2013 — Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or

U.S. FDA — Device Enforcement · United States · 2012-09-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0298-2013
Date of alert: 2012-09-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet 3i, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 2011111333

Reported risk: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.

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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