Biomet 3i recalls certain titanium dental abutments (Item IIAT3) due to a manufacturing defect where the screw stop ledge may not seat properly, potentially causing the screw to go deeper without a positive stop.
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 is recalling certain titanium dental abutments (Item IIAT3) because a manufacturing defect could cause the screw to seat deeper without a positive stop. This may lead to complications during dental implant procedures.
During manufacturing, the screw stop ledge was not made to specification, causing the screw head to seat deeper in the abutment without a positive stop. This could lead to improper implant placement or damage to surrounding structures.
Dental professionals using the recalled titanium abutments for dental implants are affected. Patients receiving these implants are at risk if they use the recalled product.
Check for the product name 'BELLATEK(R) TITANIUM ABUTMENT 3.4MM' with Item Number IIAT3. The recalled units have specific lot numbers: 8441907-1, 8441907-2, 8441907-3, 8442367-1, and 8439134A-3, 8439134A-4.
Verify the item number and lot numbers listed in the recall notice to confirm if your abutment is affected.
The screw stop ledge was not made to specification during manufacturing, which could cause the screw to seat deeper without a positive stop.
Check the item number and lot numbers against the recall list to see if your abutment is affected. If it is, contact Biomet 3i for further instructions.
The recall notice does not specify a remedy, so no immediate action is required beyond checking if the product is affected.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-2142-2019 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-2142-2019 from Biomet 3i. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.