Device recall: Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part…

Class II FDA enforcement event 61376. Recall start date: 4 Nov 2011. Status in the FDA record: Terminated. Termination date: 25 Jun 2012.

Reason for recall, in the words of FDA

On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.

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 4 Nov 2011. The firm address in the FDA record is in Palm Beach Gardens, FL. FDA put the recall in Class II. FDA event 61376 has 1 product record. The first FDA enforcement report date is 27 Jun 2012. The record gives the status Terminated, with the termination date 25 Jun 2012.

FDA enforcement report The 1 product record

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 - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.

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

1 product record in the event.

FDA event 61376: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1828-2012	Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "*Certain 3.25, 13REF IOSM313 LOT OSSEOTITE Certain Implant3.25 x 13mmCE 0086Use by yyyy-mmSterile by radiation* STERILE R*Do not re-sterile*RX only Caution: Law prohibits dispensing…	219 units in total	Class II	Terminated	27 Jun 2012

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 2011: 114
Share of these events in Class II: 89%
Product records in this event: 1Median 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
25 Nov 2015	Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants	Device	Class II	119
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

Biomet 3i, LLC: all 24 events

Official channels

FDA enforcement report Z-1828-2012The 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.

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Cite this page

Recall Register. FDA enforcement event 61376. https://recallregister.com/fda/ii/61376/. 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 - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
What quantity of product is in FDA event 61376?: The FDA record gives this quantity: 219 units in total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2011 have the same class?: 89% of the 114 device events that started in 2011 are in Class II.