Medical DeviceAug 24, 2016
Biomet 3i Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental recall — FDA Z-2417-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Recall history in this database
Classification mix: Class II: 108, Class III: 1.
Medical DeviceAug 24, 2016
Biomet 3i Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental recall — FDA Z-2419-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item recall — FDA Z-2409-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental recall — FDA Z-2509-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants recall — FDA Z-2412-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants recall — FDA Z-2408-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental recall — FDA Z-2407-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G recall — FDA Z-2410-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceAug 24, 2016
Biomet 3i Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental recall — FDA Z-2406-2016
Pouches may not have been sealed during packing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceJan 13, 2016
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 recall — FDA Z-0594-2016
Inadequate biocompatibility testing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceJan 13, 2016
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i recall — FDA Z-0591-2016
Inadequate biocompatibility testing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceJan 13, 2016
BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255 recall — FDA Z-0592-2016
Inadequate biocompatibility testing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceJan 13, 2016
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654 recall — FDA Z-0593-2016
Inadequate biocompatibility testing.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceJan 6, 2016
Biomet 3i Radiographic Transparency for Certain and External Connection Tapered Implants recall — FDA Z-0564-2016
Images contained within radiographic transparency ART 1036 are undersized.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceNov 18, 2015
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed) recall — FDA Z-0266-2016
The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking…
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceNov 18, 2015
Biomet 3i Narrow Right Angle Square Driver Tip recall — FDA Z-0267-2016
RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking…
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceSep 23, 2015
Biomet 3i UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental recall — FDA Z-2760-2015
MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceApr 22, 2015
Biomet 3i OSSEOTITE Tapered Certain Implant Rx Only recall — FDA Z-1410-2015
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceApr 22, 2015
Biomet 3i OSSEOTITE Certain 2 Implant Rx only recall — FDA Z-1411-2015
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceApr 22, 2015
Biomet 3i 3i T3 Non-Platform Switched Tapered Implant Rx Only recall — FDA Z-1409-2015
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceSep 17, 2014
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary recall — FDA Z-2594-2014
Identifiers on the label are correct but the label has the incorrect color coding.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceApr 23, 2014
BIOMET 3i Endosseous Dental Implant recall — FDA Z-1458-2014
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Class IIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 26, 2014
Biomet 3i ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone recall — FDA Z-1233-2014
Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
Class IIIFDA: TerminatedBiomet 3i, LLC
Medical DeviceMar 26, 2014
Biomet 3i Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL recall — FDA Z-1215-2014
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Class IIFDA: TerminatedBiomet 3i, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Biomet 3i, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.