PlainRecalls

Biomet 3i, LLC

Compiled from official public sources by the editorial team.

222 recalls on record · Latest: Oct 14, 2020

Biomet 3i, LLC Recall Insight

Biomet 3i, LLC appears on 222 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.218% 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 Sep 23, 2015 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

O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Extended Range Males 4pk Dental implants

FDA Devices Moderate Aug 24, 2016

O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants

FDA Devices Moderate Aug 24, 2016

Conical Abutment Pick-up Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Standard Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants

FDA Devices Moderate Aug 24, 2016

LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Temporary Non-Hexed Cylinder Dental implants

FDA Devices Moderate Aug 24, 2016

Preformance 15 degrees pre-angled post Dental implants

FDA Devices Moderate Aug 24, 2016

Standard Abutment Transfer Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Standard Abutment Temporary Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants

FDA Devices Moderate Aug 24, 2016

Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants

FDA Devices Moderate Aug 24, 2016

Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Locator Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Index Coping Surgical Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Twist Lock TM Straight Transfer Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Implant Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Conical Healing Cap Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Implant Straight Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Abutment Impression Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Certain EP Twist Lock TM Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Replacement Housing Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Cover Screw Dental implants

FDA Devices Moderate Aug 24, 2016

Implant Twist Lock TM Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Prep-tite Cap Dental implants

FDA Devices Moderate Aug 24, 2016

Conical EP Pick-Up Coping (Non-Hexed) Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Twist Lock TM Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Certain IOL Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Conical Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

DAL-RO Threaded Female Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Implant EP Twist Lock TM Coping Dental implants

FDA Devices Moderate Aug 24, 2016

IOL Pick-Up Impression Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Pick-Up Impression Coping Dental implants

FDA Devices Moderate Aug 24, 2016

Temporary Non-Hexed Cylinder Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Extra Light Angled Replacement Males 4pk Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Provide Abutment Dental implants

FDA Devices Moderate Aug 24, 2016

Cover Screw, Headless Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Preformance Post Dental implants

FDA Devices Moderate Aug 24, 2016

Certain Hex Try-in Screw (5 pk) Dental implants

FDA Devices Moderate Aug 24, 2016

Locator Extra Light Retention Males 4pk Dental implants

FDA Devices Moderate Aug 24, 2016

Gold -Tite Hexed Retaining Screw 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 13, 2016

BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, …

FDA Devices Moderate Jan 13, 2016

BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Prod…

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 Nov 18, 2015

Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant moun…

FDA Devices Moderate Nov 18, 2015

Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, hea…

FDA Devices Moderate Sep 23, 2015

UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Biomet 3i, LLC with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.