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

Class II FDA enforcement event 73184. Recall start date: 25 Nov 2015. Status in the FDA record: Terminated. Termination date: 26 Jul 2019.

Reason for recall, in the words of FDA

Pouches may not have been sealed during packing.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Biomet 3i, LLC started this device recall on 25 Nov 2015. The firm address in the FDA record is in Palm Beach Gardens, FL. FDA put the recall in Class II. FDA event 73184 has 119 product records. The first FDA enforcement report date is 24 Aug 2016. The record gives the status Terminated, with the termination date 26 Jul 2019.

FDA enforcement report The 119 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil,…

Recalling firm

Biomet 3i, LLC, Palm Beach Gardens, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

119 product records in the event.

FDA event 73184: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2406-2016	Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants	1,648,273 devices	Class II	Terminated	24 Aug 2016
Z-2407-2016	Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2408-2016	Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2409-2016	Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2410-2016	Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2411-2016	Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2412-2016	Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2413-2016	Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2414-2016	Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2415-2016	Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2416-2016	Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2417-2016	Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2418-2016	Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2419-2016	Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2420-2016	Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2421-2016	Gold-Tite Square Uniscrew Item: UNISG Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2422-2016	LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2423-2016	LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2424-2016	O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2425-2016	O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2426-2016	O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2427-2016	Locator Extended Range Males 4pk Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2428-2016	Locator Extra Light Angled Replacement Males 4pk Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2429-2016	Locator Extra Light Retention Males 4pk Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2430-2016	Locator Light Retention Replacement Males 4pk Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2431-2016	Locator Replacement Housing Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2432-2016	Locator Replacement Housing Kit Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2433-2016	Locator Replacement Males 4pk Dental implants	1,648,273 (all products subject to these recall)	Class II	Terminated	24 Aug 2016
Z-2434-2016	Pick-Up Impression Coping Dental implants	1,648,273 (all products subject to thIs recall)	Class II	Terminated	24 Aug 2016
Z-2435-2016	Preformance 15 degrees pre-angled post Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2436-2016	Preformance Post Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2437-2016	Preformance Temporary Cylinder Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2438-2016	Prep-tite Cap Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2439-2016	Prep-Tite Post Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2440-2016	Provide Impression Coping Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2441-2016	Provide Protection Cap Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2442-2016	Quickbridge TM Cap Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2443-2016	Standard Abutment Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2444-2016	Standard Abutment Pick -Up Coping Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2445-2016	Standard Abutment Temporary Screw Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2446-2016	Standard Abutment Transfer Coping Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2447-2016	Temporary Healing Retention Cylinder Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2448-2016	Temporary Hexed Cylinder Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2449-2016	Temporary Non-Hexed Cylinder Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2450-2016	Titanium Hexed Uniscrew Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2451-2016	Titanium Square Uniscrew Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2452-2016	Conical EP Healing Cap Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2453-2016	Conical EP Pick-Up Coping (Hexed) Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2454-2016	Conical EP Pick-Up Coping (Non-Hexed) Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2455-2016	Conical EP Twist Lock TM Coping Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2456-2016	Conical Healing Cap Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2457-2016	Cover Screw Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2458-2016	Cover Screw, Headless Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2459-2016	DAL-RO Housing, Female Assembly Dental implants	1,648,273devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2460-2016	DAL-RO Abutment Dental implants	1,648,273 deices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2461-2016	DAL-RO Threaded Female Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2462-2016	Drill Stop Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2463-2016	EP Healing Abutment Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2464-2016	Gingihue 15 Degree Pre-Angled Post Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016
Z-2465-2016	Gingihue Post Dental implants	1,648,273 devices (all products subject to this recall)	Class II	Terminated	24 Aug 2016

The table shows 60 of 119 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 119Median of the firm: 2
Events of the firm on the register: 24

Other events of the firm

Other FDA enforcement events of Biomet 3i, LLC
Initiated	Product (first record)	Type	Class	Records
31 Aug 2020	BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ	Device	Class II	7
10 Jan 2020	CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343	Device	Class II	23
26 Feb 2019	CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intende	Device	Class II	5
8 Mar 2017	BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit	Device	Class II	1
14 Sep 2016	BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured	Device	Class II	36
8 Aug 2016	3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.	Device	Class II	1
16 Nov 2015	Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for	Device	Class II	1
21 Sep 2015	BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are inten	Device	Class II	4
10 Aug 2015	Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry com	Device	Class II	2
29 Jul 2015	UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device	Device	Class II	1

Biomet 3i, LLC: all 24 events

Official channels

FDA enforcement report Z-2406-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 73184. https://recallregister.com/fda/ii/73184/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil,…
What quantity of product is in FDA event 73184?: The event has 119 product records. The first record gives this quantity: 1,648,273 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.