CERTAIN BELLATEK recallZ-2142-2019 · Biomet 3i, LLC · initiated Feb 26, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet 3i, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.
Recall details
- Recall number
- Z-2142-2019
- Status
- Terminated
- Initiated by the company
- Feb 26, 2019
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 6 units
- Product code
- NHA
- FDA submissions
- K052648, K102209
- Distribution
- Nationwide and Puerto Rico, Canada, and Australia
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CERTAIN® BELLATEK® IIAT3ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 82263).
- Z-2140-2019 · TerminatedCERTAIN(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 …
- Z-2141-2019 · TerminatedCERTAIN(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…
- Z-2143-2019 · TerminatedCERTAIN(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 …
- Z-2144-2019 · TerminatedCERTAIN(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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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