Biomet 3i, LLC recalls
Every recall we track for Biomet 3i, LLC — 35 in all, from 2019–2020 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Biomet 3i, LLC peaked in 2020 (30); 35 since 2017.
All FDA recall records for Biomet 3i, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 2 | 3 | 0 | 5 |
| 2020 | 0 | 2 | 28 | 0 | 30 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Biomet 3i, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Biomet 3i, LLC recalls
3 shown- Lower riskMedical device
Biomet 3i, LLC recalls BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Biomet recalls Bellatek Titanium Abutment 4.1mm (EDAT4) due to manufacturing misalignment risk. This may cause improper placement during dental procedures.
BiometAug 31, 2020 - Lower riskMedical device
Biomet 3i, LLC recalls CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Biomet recalls certain Healing Abutments (IEHA353, Lot 1228667) due to potential 30-degree rotation error affecting dental implants. Affected users should contact Biomet for details.
BiometJan 10, 2020 - Use cautionMedical device
Biomet 3i, LLC recalls CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are
Biomet 3i recalls certain tin abutments 3.4mm (item ILDAN3) due to screw over-driving risk. Affected units have specific lot numbers. Stop using immediately to prevent damage.
Biomet 3iFeb 26, 2019
Biomet 3i, LLC recall questions
How many recalls has Biomet 3i, LLC had?
35 recalls from Biomet 3i, LLC are on record with U.S. safety agencies, from 2019–2020.
What is the most recent Biomet 3i, LLC recall?
Biomet 3i, LLC recalls BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4, dated Aug 31, 2020. Every Biomet 3i, LLC recall is listed on this page, newest first.
What should I do if I have a recalled Biomet 3i, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Biomet 3i, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.