PlainRecalls

Biomet 3i, LLC

139 recalls on record · Latest: Oct 14, 2020

Biomet 3i, LLC Recall Insight

Biomet 3i, LLC appears on 139 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.166% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Oct 14, 2020, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Aug 24, 2016 to Oct 14, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Oct 14, 2020

BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4

FDA Devices Moderate Oct 14, 2020

CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5

FDA Devices Moderate Oct 14, 2020

CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4

FDA Devices Moderate Oct 14, 2020

CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4

FDA Devices Moderate Oct 14, 2020

BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563

FDA Devices Moderate Mar 4, 2020

CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554

FDA Devices Moderate Mar 4, 2020

CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to …

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessor…

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessor…

FDA Devices Moderate Aug 14, 2019

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to …

FDA Devices Moderate Apr 5, 2017

BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connec…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected …

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected …

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly con…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly co…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly conne…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connec…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic compone…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly co…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component d…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic comp…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly …

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

FDA Devices Moderate Dec 28, 2016

BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directl…

FDA Devices Moderate Sep 28, 2016

3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.

FDA Devices Moderate Aug 24, 2016

Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds