Class 2 Device Recall CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM

• Date Initiated by Firm: February 26, 2019
• Create Date: August 02, 2019
• Recall Status: Terminated on June 15, 2020
• Recall Number: Z-2144-2019
• Recall Event ID: 82263
• 510(K)Number: K052648 K102209
• Product Classification: Abutment, implant, dental, endosseous - Product Code NHA
• 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Biomet 3i, LLC; 4555 Riverside Dr; Palm Beach Gardens FL 33410-4200
• For Additional Information Contact: Zimmer Biomet, Customer Service; 888-800-8045
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.
• Quantity in Commerce: 49 units
• Distribution: Nationwide and Puerto Rico, Canada, and Australia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NHA; 510(K)s with Product Code = NHA