Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biomet 3i with 222 device recalls and 32 510(k) clearances. The most recent is a 510(k) clearance dated Jun 27, 2025: T3 Pro Implants– ZimVie Packaging System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 27, 2025 | T3 Pro Implants– ZimVie Packaging SystemK251660 · DZE | 510(k) clearances |
| Oct 23, 2024 | Immediate Molar ImplantsK241753 · DZE | 510(k) clearances |
| Jul 15, 2024 | BellaTek BarsK241032 · NHA | 510(k) clearances |
| Sep 14, 2022 | TSX ImplantsK220978 · DZE | 510(k) clearances |
| Mar 28, 2022 | T3 Pro ImplantsK213672 · DZE | 510(k) clearances |
| Dec 21, 2021 | BellaTek Encode Emergence Healing AbutmentsK212730 · NHA | 510(k) clearances |
| Aug 31, 2020 | BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4Class II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Aug 31, 2020 | CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5Class II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Aug 31, 2020 | CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4Class II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Aug 31, 2020 | CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4Class II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Aug 31, 2020 | BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQClass II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Aug 31, 2020 | CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6Class II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Aug 31, 2020 | CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5Class II · Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the p | Device recalls |
| Jan 10, 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353Class II · Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of app | Device recalls |
| Dec 9, 2019 | TSV BellaTek Express and BellaTek Flex AbutmentsK192522 · NHA | 510(k) clearances |
| Jul 2, 2019 | Certain BellaTek Express and BellaTek Flex AbutmentsK183138 · NHA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
