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

Recall Z-1411-2015 — OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

U.S. FDA — Device Enforcement · United States · 2014-11-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1411-2015
Date of alert
2014-11-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet 3i, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2014051368
Reported risk: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
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.

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