medical Class II Updated 2019-08-14

Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number

Recalled Product

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers/UDI: 8442579-2/(01)00844868031390(10)8442579-2 8442701-1/(01)00844868031390(10)8442701-1 8442701-3/(01)00844868031390(10)8442701-3 8442692-1/(01)00844868031390(10)8442692-1 8442681-1/(01)00844868031390(10)8442681-1 8442663-1/(01)00844868031390(10)8442663-1 8442688-1/(01)00844868031390(10)8442688-1 8442837-1/(01)00844868031390(10)8442837-1 8442837-2/(01)00844868031390(10)8442837-2 8442657-1/(01)00844868031390(10)8442657-1 8442657-2/(01)00844868031390(10)8442657-2 8442674-1/(01)00844868031390(10)8442674-1 6867796-1/(01)00844868031390(10)6867796-1 8442805-1/(01)00844868031390(10)8442805-1 8442895-1/(01)00844868031390(10)8442895-1 8442811-1/(01)00844868031390(10)8442811-1 8442841-1/(01)00844868031390(10)8442841-1 8442720-1/(01)00844868031390(10)8442720-1 8442799-2/(01)00844868031390(10)8442799-2 8442765-1/(01)00844868031390(10)8442765-1 8442914-2/(01)00844868031390(10)8442914-2 8442944-1/(01)00844868031390(10)8442944-1 8443029-2/(01)00844868031390(10)8443029-2 8442940-2/(01)00844868031390(10)8442940-2 8443035-1/(01)00844868031390(10)8443035-1 8442948-1/(01)00844868031390(10)8442948-1 8443044-1/(01)00844868031390(10)8443044-1 8442965-1/(01)00844868031390(10)8442965-1 8442954-1/(01)00844868031390(10)8442954-1 8442949-1/(01)00844868031390(10)8442949-1 8442970-1/(01)00844868031390(10)8442970-1 8442930-1/(01)00844868031390(10)8442930-1 8443242-1/(01)00844868031390(10)8443242-1 8443098-1/(01)00844868031390(10)8443098-1 8442937-1/(01)00844868031390(10)8442937-1 8443046-1/(01)00844868031390(10)8443046-1 8442927-1/(01)00844868031390(10)8442927-1 8442936-1/(01)00844868031390(10)8442936-1 8442935-1/(01)00844868031390(10)8442935-1 8442997-1/(01)00844868031390(10)8442997-1 8443187-1/(01)00844868031390(10)8443187-1 8443018-1/(01)00844868031390(10)8443018-1 8443010-1/(01)00844868031390(10)8443010-1 8443230-1/(01)00844868031390(10)8443230-1 8443102-1/(01)00844868031390(10)8443102-1 8443231-1/(01)00844868031390(10)8443231-1 8443193-1/(01)00844868031390(10)8443193-1 8443248-1/(01)00844868031390(10)8443248-1 8443213-1/(01)00844868031390(10)8443213-1
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