Recall Z-0075-2021— Biomet 3i, LLC

Name: FDA recall Z-0075-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Class II · Terminated

Class II FDA medical device recall by Biomet 3i, LLC, initiated 2020-08-31, terminated 2022-07-06. It names one FDA 510(k) clearance: K052648. Product: CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4. Reason: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient.

Recalling firm: Biomet 3i, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Terminated: 2022-07-06
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K052648 — MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARSImplant Innovations, Inc.·cleared 2005-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

Reason for recall

Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient

Data sourced from openFDA. This site is unofficial and independent of the FDA.