FDA recall Z-2144-2019

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

Reason for recall

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.

Distribution

Nationwide and Puerto Rico, Canada, and Australia

Key facts

Status

Terminated

Initiation date

2019-02-26

Report date

2019-08-14

Termination date

2020-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Beach Gardens, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2144-2019