Biomet 3I, LLC
United StatesFDA applicant, unverified
Biomet 3I, LLC is a medical device manufacturer, with 32 devices listed in FDA 510(k) (FDA Class II) and 245 FDA recalls as of 12 Nov 2026.
- Devices
- 32
- FDA recalls
- 245
Registry facts
- Registries
- FDA 510(k) 32
- Device classes
- FDA Class II 32
- FDA recalls
- Identifiers
- DUNS 186127825
At a glance
Market reach
- United States
- FDA recalls
What Biomet 3I, LLC makes
BIOMET 3I, LLC manufactures dental implants and related products, including screw endosteal implants, both permanent and temporary suprastructure components, dental drill bits (reusable and single-use), surgical screwdrivers, and bone taps.
The company's products are regulated as Class I and Class II medical devices and are listed in the FDA UDI registry.
Catalogue
Search and filter all 32 devicesCompany details
- DUNS number
- 186127825
- 3iPBG-CS@biomet.com
- Phone
- +1(800)342-5454
FDA recalls
FDA recall records list 245 recalls initiated by BIOMET 3I, LLC, the earliest on 2006-10-16 and the most recent on 2020-08-31. By recorded status: 245 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 5
- 2020 30
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 31 Aug 2020 Z-0073-2021 Class II Terminated 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
- 31 Aug 2020 Z-0074-2021 Class II Terminated 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
- 31 Aug 2020 Z-0075-2021 Class II Terminated 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
- 31 Aug 2020 Z-0076-2021 Class II Terminated 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
- 31 Aug 2020 Z-0077-2021 Class II Terminated 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
- 31 Aug 2020 Z-0078-2021 Class II Terminated 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
- 31 Aug 2020 Z-0079-2021 Class II Terminated 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
- 10 Jan 2020 Z-1366-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1367-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1368-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Show the 25 most recent of 245 recalls
2020
- 10 Jan 2020 Z-1369-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1370-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1371-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1372-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1373-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1374-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1375-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1376-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1377-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1378-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1379-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1380-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1381-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1382-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
- 10 Jan 2020 Z-1383-2020 Class II Terminated Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Frequently asked questions
How many devices does BIOMET 3I, LLC have in the registry?
The registry currently lists 32 devices for BIOMET 3I, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOMET 3I, LLC's devices?
Among its 32 most recently registered devices, BIOMET 3I, LLC has devices listed in FDA 510(k) (32 devices).
What risk classes do BIOMET 3I, LLC's devices fall under?
Among its 32 most recently registered devices, the classes recorded for BIOMET 3I, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for BIOMET 3I, LLC?
FDA recall records list 245 recalls initiated by BIOMET 3I, LLC, the most recent initiated on 31 Aug 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from BIOMET 3I, LLC in the registry?
The most recently registered devices listed for BIOMET 3I, LLC include ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION, BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS, CAM STRUCTSURE PRECISION MILLED BARS and INTERGRO ORAL.