Palm Beach Gardens, FL, United States
Biomet 3i, LLC recalls
3 recalls recorded since 2018, most recently on 31 August 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 31 August 2020
- Terminated
- 6 July 2022
- 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
- Distribution
- FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0074-2021, Z-0078-2021, Z-0075-2021, Z-0077-2021, Z-0073-2021, Z-0079-2021, Z-0076-2021
- BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
- CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
- CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
- CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
- BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
- CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
Terminated Class II Medical devices
- Recall started
- 10 January 2020
- Terminated
- 2 August 2021
- Reason
- 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
- Distribution
- Nationwide Foreign: Australia Austria Belgium China France Germany Italy Japan Netherlands Poland Spain UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1369-2020, Z-1380-2020, Z-1373-2020, Z-1387-2020, Z-1366-2020, Z-1376-2020, Z-1371-2020, Z-1385-2020, Z-1384-2020, Z-1367-2020, Z-1374-2020, Z-1382-2020 and 11 more
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
- CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
- and 15 more product lines
Terminated Class II Medical devices
- Recall started
- 26 February 2019
- Terminated
- 15 June 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2143-2019, Z-2142-2019, Z-2141-2019, Z-2140-2019, Z-2144-2019
- CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandib
- CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandib
- CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
- 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 mandibl
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.