Recall Z-2141-2019 — CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
U.S. FDA — Device Enforcement · United States · 2019-02-26 · Class II
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Reported risk: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
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