Biomet 3i, LLC
Biomet 3i, LLC holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2025, with 222 FDA device recalls on record.
Top product codes for Biomet 3i, LLC
FDA recalls by Biomet 3i, LLC
10 most recent of 222- Z-0079-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
- Z-0075-2021 — CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4
- Z-0074-2021 — BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
- Z-0077-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4
- Z-0076-2021 — CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5
- Z-0073-2021 — BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
- Z-0078-2021 — CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5
- Z-1369-2020 — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
- Z-1376-2020 — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
- Z-1384-2020 — CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biomet 3i, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.