Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Device

Biomet 3i, LLC: Pouches may not have been sealed during packing.

Agency Publication Date: August 12, 2016
Share:
Sign in to monitor this recall

Affected Products

Product: Preformance 15 degrees pre-angled post Dental implants

Item: MPAPF34, MPAPF36, PAPF454, PAPF456, PAPF554, PAPF556 and PAPF666

Product: Preformance Post Dental implants

Item: MPFP34, MPFP36, PFP454, PFP456, WPFP554, WPFP556 and WPFP666.

Product: Preformance Temporary Cylinder Dental implants

Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.

Product: Prep-tite Cap Dental implants

Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.

Product: Prep-Tite Post Dental implants

Item: APP42, WPP552 and WPP662.

Product: Provide Impression Coping Dental implants

Item:PIC484, PIC485, PIC654, PIC655, PIC484H, PIC485H and PIC654H.

Product: Provide Protection Cap Dental implants

Item: PPC484, PPC485, PPC654 and PPC655.

Product: Quickbridge TM Cap Dental implants

Item: QBCAP

Product: Standard Abutment Dental implants

Item: AB200, AB300, AB400, AB500 and AB700.

Product: Standard Abutment Pick -Up Coping Dental implants

Item: SQIC7

Product: Standard Abutment Temporary Screw Dental implants

Item: TS250

Product: Standard Abutment Transfer Coping Dental implants

Item: SIC70

Product: Temporary Healing Retention Cylinder Dental implants

Item: THRC4 and THRC6.

Product: Temporary Hexed Cylinder Dental implants

Item: MMTCS1, ITCS41, WTCS51 and WTCS61.

Product: Temporary Non-Hexed Cylinder Dental implants

Item: ITCS42, WTCS52 and WTCS62.

Product: Titanium Hexed Uniscrew Dental implants

Item: UNIHT

Product: Titanium Square Uniscrew Dental implants

Item: UNIST

Product: Conical EP Healing Cap Dental implants

Item: CS250, CS260 and CS270.

Product: Conical EP Pick-Up Coping (Hexed) Dental implants

Item:CNRIC

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

Item: CSQ17, CSQ06 and CSQ07.

Product: Conical EP Twist Lock TM Coping Dental implants

Item: CIC55, CIC56 and CIC57.

Product: Conical Healing Cap Dental implants

Item: MHC33

Product: Cover Screw Dental implants

Item: CS375, CS500 and CS600.

Product: Cover Screw, Headless Dental implants

Item: CS275

Product: DAL-RO Housing, Female Assembly Dental implants

Item: DRTH

Product: DAL-RO Abutment Dental implants

Items: DRH20, DRH40 and DRH60

Product: DAL-RO Threaded Female Dental implants

Item: DRAF

Product: Drill Stop Dental implants

Item: DS2310, DS2315, DS2320, DS4513, DS4518 and DS458

Product: EP Healing Abutment Dental implants

Items: MHA32, MHA33, MHA34, MHA36, THA58, THA63, THA64, THA66, THA68, THA73, THA74, THA76, THA78, WTH52, WTH53, WTH54, WTH56, WTH58, WTH562, WTH563, WTH564, WTH566, WTH568, WTH572, WTH573, WTH574, WTH576, WTH578, WTH62, WTH63, WTH64, WTH66, WTH68, WTH672, WTH673, WTH674, WTH676 and WTH678.

Product: Gingihue 15 Degree Pre-Angled Post Dental implants

Items: MPAP32G, MPAP34G, PAP454G, PAP462G, PAP464G, PAP472G, PAP474G, PAP552G, PAP554G, PAP562G, PAP564G, PAP572G, PAP574G, PAP662G, PAP664G, PAP672G and PAP674G.

Product: Gingihue Post Dental implants

Items: MAP32G, MAP34G, APP462G, APP464G, APP472G, APP474G, WPP554G, WPP562G, WPP564G, WPP572G, WPP574G, WPP662G, WPP664G, WPP672G and WPP674G.

Product: Gold Slotted Screw Dental implants

Items: GS200 and GS300.

Product: Gold -Tite Hexed Retaining Screw Dental implants

Items: GS200 and GS300.

Product: Healing Abutment Dental implants

Items: THA42, THA43, THA44, THA46 and THA48.

Product: Implant Cover Screw Dental implants

Item: MMCS1

Product: Implant EP Pick-Up Coping Dental implants

Items: IIC60, IIC75, WIP55, WIP56, WIP57, WIP66 and WIP67

Product: Implant EP Twist Lock TM Coping Dental implants

Items: IIC46, IIC47, WIT56, WIT57, WIT55, WIT66 and WIT67

Product: Implant Twist Lock TM Coping Dental implants

Item: IIC44.

Product: Index Coping Surgical Dental implants

Item: IC100.

Product: IOL Abutment and Screw Dental implants

Items: IOL20T, IOL55T and IOL70T

Product: IOL Distal Extension Dental implants

Item: IOLDE

Product: IOL Healing Cap Dental implants

Item: IOLHC

Product: IOL Pick-Up Impression Coping Dental implants

Item: IOLPIC

Product: IOL Titanium Temporary Cylinder Dental implants

Item: IOLTC

Product: IOL Transfer Impression Coping Dental implants

Item: IOLTIC

Product: Locator Abutment Dental implants

Items: MLOA001, MLOA002, MLOA003, MLOA004, MLOA005, MLOA006, LOA001, LOA002, LOA003, LOA004, LOA005 and LOA006.

Product: Locator Abutment Impression Coping Dental implants

Item: LAIC1.

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

Item: IUNITS

Product: Certain Implant Cover Screw Dental implants

Items: ICS375, ICS500 and ICS600.

Product: Certain Implant EP Twist Lock TM Coping Dental implants

Item: IWIT67

Product: Certain Implant Straight Cover Screw Dental implants

Item: ICS400

Product: Certain IOL Abutment Dental implants

Items: IIOL55S and IIOL70S

Product: Certain Locator Abutment Dental implants

Items: IMLOA001, IMLOA002, IMLOA003, IMLOA004, IMLOA005, IMLOA006, ILOA001, ILOA002, ILOA003, ILOA004, ILOA005, and ILOA006.

Product: Certain Micromini Flat Implant Cover Screw Dental implants

Item: IMCSF34

Product: Certain Non-Hexed Implant Pick-up Coping Dental implants

Item: IMCSF34

Product: Certain Pick-up Coping Dental implants

Items: IMIC33, IIIC60, IIIC75, IWIP56, IWIP57, IWIP66 and IWIP67.

Product: Certain Preformance 15 degrees Pre-Angled Post Dental implants

Items: IMPAPF36, IMPAPF354 and IMPAPF356.

Product: Certain Preformance Post Dental implants

Items: IMPFP34, IMPFP36, IMPFP354, IMPFP356, IPFP456, IWPFP554, IWPFP556, IWPFP664 and IWPFP666.

Product: Certain Preformance Temporary Cylinder Dental implants

Items: IMPFTC34, IMPFTC32, IPFTC41, IPFTC42, IWPFTC51, IWPFTC52, IWPFTC61 and IWPFTC62.

Product: Certain Provide Abutment Dental implants

Items: IPA4140, IPA4155, IPA4240, IPA4255, IPA4340, IPA4355, IPA4440, IPA4455, IPA5140, IPA5155, IPA5240, IPA5255, IPA5340, IPA5355, IPA5440, IPA5455, IPA6140, IPA6155, IPA6240, IPA6255, IPA6340, IPA6355, IPA6440 and IPA6455.

Product: Certain Standard Abutment Dental implants

Items: IAB200, IAB300, IAB400, IAB550 and IAB700.

Product: Certain Straight Healing Abutment Dental implants

Items: ISMHA32, ISMHA33, ISMHA34, ISMHA36, ISHA46, ISHA48, ISWHA52, ISWHA53, ISWHA54, ISWHA56, ISWHA58, ISWHA62, ISWHA63, ISWHA64, ISWHA66 and ISWHA68.

Product: Certain Straight Pick Up Coping Dental implants

Items: IMIC30 and IWIP60

Product: Certain Temporary Hexed Cylinder Dental implants

Items: IMMTCS1, IITCS41, IWTCS51 and IWTCS61.

Product: Certain Temporary Non-Hexed Cylinder Dental implants

Items: IITCS42, IWTCS52 and IWTCS62.

Product: Certain Titanium Large Hexed Screw Dental implants

Item: ILRGHT

Product: Certain Twist Lock TM Coping Dental implants

Items: IIIC46, IIIC47, IWIT55, IWIT56 and IWIT57.

Product: Certain Twist Lock TM Straight Transfer Coping Dental implants

Items: IWIT50 and IWIT60.

Product: Certain Twist Lock TM Coping Dental implants

Item: IWIT66.

Product: Conical 17 degree Angled Abutment Dental implants

Items: AC4217 and AC4417.

Product: Conical 25 degree Angled Abutment Dental implants

Items: AC4225 and AC4425.

Product: Conical Abutment Dental implants

Items: MCA31, MCA33, MCA34, CA001, CA002, CA004, WCA51 and WCA53.

Product: Conical Abutment Gold Standard ZR TM Dental implants

Items: SCA001, SCA002, SCA003, SCA004, SCA055, SWCA51, SWCA52, SWCA53, SWCA54 and SWCA55.

Product: Conical Abutment Pick-up Coping Dental implants

Item: MEC33.

Product: Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants

Lot No. 1152783

Product: Bellatek Encode Healing Abutment Dental implants

Items: EHA343, EHA344, EHA346, EHA348, EHA353, EHA354, EHA356, EHA358, EHA443, EHA444, EHA446, EHA448, EHA453, EHA454, EHA456, EHA458, EHA463, EHA464, EHA466, EHA468, EHA473, EHA474, EHA476, EHA478, EHA553, EHA554, EHA556, EHA558, EHA563, EHA564, EHA566, EHA568, EHA573, EHA574, EHA576. EHA578, EHA663, EHA664, EHA666, EHA668, EHA673, EHA674, EHA676 and EHA678.

Product: Certain EP Twist Lock TM Coping Dental implants

Item: IMIT33

Product: Certain Bellatek Encode Healing Abutment Dental implants

Items: IEHA343, IEHA344, IEHA346, IEHA348, IEHA353, IEHA354, IEHA356, IEHA358, IEHA443, IEHA444, IEHA446, IEHA448, IEHA453, IEHA454, IEHA456, IEHA458, IEHA463, IEHA464, IEHA466, IEHA468, IEHA473, IEHA474, IEHA476, IEHA478, IEHA553, IEHA554, IEHA556, IEHA558, IEHA563, IEHA564, IEHA566, IEHA568, IEHA573, IEHA574, IEHA576. IEHA578, IEHA663, IEHA664, IEHA666, IEHA668, IEHA673, IEHA674, IEHA676 and IEHA678.

Product: Certain Conical 17 degree Angled Abutment Dental implants

Items: IAC4217 and IAC4417

Product: Certain Conical 25 degree Angled Abutment Dental implants

Items: IAC4225 and IAC4425

Product: Certain Conical Abutment Dental implants

Items: IMCA31, IMCA32, IMCA33, IMCA34, ICA001, ICA002, ICA003, ICA004, IWCA51, IWCA52, IWCA53, IWCA54 and IWCA55.

Product: Certain Cover Screw Dental implants

Item: IMMCS1

Product: Certain EP Healing Abutment Dental implants

Items: IMHA352, IMHA353, IMHA356, ITHA58, ITHA63, ITHA64, ITHA66. ITHA68, ITHA73, ITHA74, ITHA76, ITHA78, IWTH52, IWTH54, IWTH56, IWTH58, IWTH562, IWTH564, IWTH566, IWTH568, IWTH572, IWTH573, IWTH574, IWTH576, IWTH578, IWTH62, IWTH63, IWTH64, IWTH66, IWTH68, IWTH672, IWTH673, IWTH674, IWTH676 AND IWTH678.

Product: Certain EP Pick-Up Coping Dental implants

Item: IMIC35

Product: Certain EP Twist Lock TM Coping Dental implants

Item: IMIT35

Product: Certain Flat Implant Cover Screw Dental implants

Items: ICSF41, ICSF50 and ICSF60

Product: Certain Gingihue TM 15 degree Angled Post Dental implants

Item: IMPAP34G

Product: Certain Gingihue 15 degree Pre- Angled Post Dental implants

Items: IMPAP352G and IMPAP354G

Product: Certain Gingihue Post Dental implants

Items: IMAP352G, IMAP354G, IAPP462G, IAPP464G, IAPP472G, IAPP474G, IWPP564G, IWPP572G, IWPP574G, IWPP662G, IWPP664G, IWPP672G AND IWPP674G.

Product: Certain Gingihue 15 degree Angled Post Dental implants

Items: IPAP464G, IPAP472G, IPAP474G, IPAP462G, IPAP554G, IPAP562G, IPAP564G, IPAP572G, IPAP574G, IPAP662G, IPAP664G, IPAP672G AND IPAP674G.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73184
Status: Resolved
Manufacturer: Biomet 3i, LLC
Manufactured In: United States
Units Affected: 90 products (1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273devices (all products subject to this recall); 1,648,273 deices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1, 648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall.; 1,648,273 devices (all products subject to this recall).; 1,648,273 devices (all products subject to this recall).; 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall); 1,648,273 devices (all products subject to this recall))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.