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 39 entries, severity tagging shows 0 critical, 38 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 39 of 39 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 (39). The date window on this page runs from Jun 27, 2012 to Aug 24, 2016.

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 Aug 24, 2016

Healing Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Replacement Housing Kit Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants

FDA Devices Moderate Aug 24, 2016

Implant Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

IOL Abutment and Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Drill Stop Dental implants

FDA Devices Moderate Aug 24, 2016

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants

FDA Devices Moderate Aug 24, 2016

Provide Impression Coping Dental implants

FDA Devices Moderate Aug 24, 2016

O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants

FDA Devices Moderate Aug 24, 2016

Standard Abutment Pick -Up Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Implant EP Twist Lock TM Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Temporary Hexed Cylinder Dental implants

FDA Devices Moderate Aug 24, 2016

Conical EP Pick-Up Coping (Hexed) Dental implants

FDA Devices Moderate Aug 24, 2016

Conical 17 degree Angled Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Prep-Tite Post Dental implants

FDA Devices Moderate Aug 24, 2016

Titanium Hexed Uniscrew Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Flat Implant Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Titanium Large Hexed Screw Dental implants

FDA Devices Moderate Aug 24, 2016

EP Healing Abutment Dental implants

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an…

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessor…

FDA Devices Moderate Jan 6, 2016

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

FDA Devices Moderate Apr 22, 2015

OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.

FDA Devices Moderate Apr 22, 2015

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

FDA Devices Moderate Sep 17, 2014

BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft …

FDA Devices Moderate Apr 23, 2014

BIOMET 3i Endosseous Dental Implant.

FDA Devices Low Mar 26, 2014

ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantati…

FDA Devices Moderate Mar 26, 2014

Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconi…

FDA Devices Moderate Mar 19, 2014

Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

FDA Devices Moderate Mar 19, 2014

Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

FDA Devices Moderate Sep 25, 2013

Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provid…

FDA Devices Moderate Aug 21, 2013

Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L)

FDA Devices Moderate Aug 21, 2013

Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)

FDA Devices Moderate Nov 28, 2012

Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides a means for prosthetic …

FDA Devices Moderate Oct 31, 2012

Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to…

FDA Devices Moderate Sep 5, 2012

Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cy…

FDA Devices Moderate Aug 15, 2012

***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, …

FDA Devices Moderate Jun 27, 2012

Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313…

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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