Biomet 3I
FDA adverse event reports naming Biomet 3I as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOMET 3I.
- Total reports
- 18,760
- Deaths
- 0
- Injuries
- 12,395
- Malfunctions
- 6,364
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implant, Endosseous, Root-FormDZE13,087
- Abutment, Implant, Dental, EndosseousNHA4,657
- Accessories, Implant, Dental, EndosseousNDP866
- Screw, Fixation, BoneHWC77
- Screw, Fixation, IntraosseousDZL26
- Driver, ProsthesisHWR7
- Crown, PreformedELZ6
- Bone Grafting Material, Human SourceNUN6
- Restoration, PorcelainNSP5
- Drill, Dental, IntraoralDZA4
Recent recalls
- 2016-08-12TerminatedPackaging
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
Pouches may not have been sealed during packing.
- 2016-08-12TerminatedPackaging
Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
Pouches may not have been sealed during packing.
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