Use cautionMedical device recall · FDA · Published February 26, 2019
Biomet 3i Recall: Tin Abutment 3.4MM Risk of Screw Over-Driving
Biomet 3i recalls certain tin abutments 3.4mm (item ILDAN3) due to screw over-driving risk. Affected units have specific lot numbers. Stop using immediately to prevent damage.
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
“Biomet 3i Recall: Tin Abutment 3.4MM Risk of Screw Over-Driving.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68938-biomet-3i-recall-tin-abutment-3-4mm-risk-of-screw. Based on FDA recall #Z-2143-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2019%22&limit=1).
The FDA announced on Feb. 26, 2019, that Biomet 3i, LLC voluntarily recalled certain CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM dental implants due to manufacturing defects. The company initiated the Class II recall after determining the screw stop ledge was not made to specification.
How to tell if you have it
Brand: Biomet 3i
Product: CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM
Item Number: ILDAN3
UPC: 00844868031352
Lot Numbers/UDI: 8442561-2/(01)00844868031352(10)8442561-2, 8442561-3/(01)00844868031352(10)8442561-3
Distribution: Nationwide and Puerto Rico, Canada, and Australia
The hazard
According to the FDA, during manufacturing, the screw stop ledge was not made to specification and location within the abutment. This resulted in the screw head seating deeper in the abutment with no positive stop.
Context
GovInfoNow's records show Biomet 3i, LLC has two other recalls on record since Jan. 10, 2020. On Aug. 31, 2020, the company recalled Bellatek Tin Abutment 4.1MM due to a misaligned hex risk in dental implants. Other recent recalls of similar products include Straumann Dental Implant Abutments Recall: Incorrect Screw Seat Interface Hazard (March 27, 2026) and Straumann Custom Abutment AS Ti Recall: Material Mix-Up Risk (March 17, 2026).
How to tell if you have this one
Check for item number ILDAN3 on the abutment. Affected units have specific lot numbers: 8442561-2, 8442561-3 with UDI codes starting with 0100844868031352.
Brand
Biomet 3i
Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide and Puerto Rico, Canada, and Australia
Recall number
Product, codes & lots
Quantity
Z-2140-2019
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible; Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1
3 units
Z-2141-2019
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible; Lot Numbers/UDI: 8442191-1/(01)00844868031178(10)8442191-1 8442751-1/(01)00844868031178(10)8442751-1 8441857-1/(01)00844868031178(10)8441857-1 8442548-1/(01)00844868031178(10)8442548-1 8442504-1/(01)00844868031178(10)8442504-1 8442556-1/(01)00844868031178(10)8442556-1 8442556-2/(01)00844868031178(10)8442556-2 8442556-3/(01)00844868031178(10)8442556-3 8442556-4/(01)00844868031178(10)8442556-4 8443047-1/(01)00844868031178(10)8443047-1 8443059-1/(01)00844868031178(10)8443059-1 8443071-2/(01)00844868031178(10)8443071-2 8443071-3/(01)00844868031178(10)8443071-3 8443085-1/(01)00844868031178(10)8443085-1 8442164-1/(01)00844868031178(10)8442164-1 8443036-1/(01)00844868031178(10)8443036-1 8443036-2/(01)00844868031178(10)8443036-2
17 units
Z-2142-2019
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible; Lot Numbers/UDI: 8441907-1/(01)00844868031284(10)8441907-1 8441907-2/(01)00844868031284(10)8441907-2 8441907-3/(01)00844868031284(10)8441907-3 8442367-1/(01)00844868031284(10)8442367-1 8439134A-3/(01)00844868031284(10)8439134A-3 8439134A-4/(01)00844868031284(10)8439134A-4
6 units
Z-2143-2019
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible; Lot Numbers/UDI: 8442561-2/(01)00844868031352(10)8442561-2 8442561-3/(01)00844868031352(10)8442561-3
2 units
Z-2144-2019
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible; Lot Numbers/UDI: 8442579-2/(01)00844868031390(10)8442579-2 8442701-1/(01)00844868031390(10)8442701-1 8442701-3/(01)00844868031390(10)8442701-3 8442692-1/(01)00844868031390(10)8442692-1 8442681-1/(01)00844868031390(10)8442681-1 8442663-1/(01)00844868031390(10)8442663-1 8442688-1/(01)00844868031390(10)8442688-1 8442837-1/(01)00844868031390(10)8442837-1 8442837-2/(01)00844868031390(10)8442837-2 8442657-1/(01)00844868031390(10)8442657-1 8442657-2/(01)00844868031390(10)8442657-2 8442674-1/(01)00844868031390(10)8442674-1 6867796-1/(01)00844868031390(10)6867796-1 8442805-1/(01)00844868031390(10)8442805-1 8442895-1/(01)00844868031390(10)8442895-1 8442811-1/(01)00844868031390(10)8442811-1 8442841-1/(01)00844868031390(10)8442841-1 8442720-1/(01)00844868031390(10)8442720-1 8442799-2/(01)00844868031390(10)8442799-2 8442765-1/(01)00844868031390(10)8442765-1 8442914-2/(01)00844868031390(10)8442914-2 8442944-1/(01)00844868031390(10)8442944-1 8443029-2/(01)00844868031390(10)8443029-2 8442940-2/(01)00844868031390(10)8442940-2 8443035-1/(01)00844868031390(10)8443035-1 8442948-1/(01)00844868031390(10)8442948-1 8443044-1/(01)00844868031390(10)8443044-1 8442965-1/(01)00844868031390(10)8442965-1 8442954-1/(01)00844868031390(10)8442954-1 8442949-1/(01)00844868031390(10)8442949-1 8442970-1/(01)00844868031390(10)8442970-1 8442930-1/(01)00844868031390(10)8442930-1 8443242-1/(01)00844868031390(10)8443242-1 8443098-1/(01)00844868031390(10)8443098-1 8442937-1/(01)00844868031390(10)8442937-1 8443046-1/(01)00844868031390(10)8443046-1 8442927-1/(01)00844868031390(10)8442927-1 8442936-1/(01)00844868031390(10)8442936-1 8442935-1/(01)00844868031390(10)8442935-1 8442997-1/(01)00844868031390(10)8442997-1 8443187-1/(01)00844868031390(10)8443187-1 8443018-1/(01)00844868031390(10)8443018-1 8443010-1/(01)00844868031390(10)8443010-1 8443230-1/(01)00844868031390(10)8443230-1 8443102-1/(01)00844868031390(10)8443102-1 8443231-1/(01)00844868031390(10)8443231-1 8443193-1/(01)00844868031390(10)8443193-1 8443248-1/(01)00844868031390(10)8443248-1 8443213-1/(01)00844868031390(10)8443213-1
49 units
Based on the official FDA remedy
What to do — step by step
Check Abutment Details
Look for item number ILDAN3 and specific lot numbers on the abutment.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide and Puerto Rico, Canada, and Australia” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2143-2019 (February 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2143-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.