Biomet 3i recalls certain titanium dental abutments (item IEDAT3) due to manufacturing defect where screw may seat deeper without positive stop. Affected units have specific lot numbers.
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 that may cause screws to seat too deeply without a positive stop. This defect could lead to complications during dental implant procedures if the abutment is used as intended.
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 potentially lead to complications during dental implant procedures if the abutment is used as intended.
Dental professionals using Biomet 3i's titanium abutments for dental implants are most at risk. Affected units have specific lot numbers listed in the recall notice.
Check for the item number IEDAT3 on the abutment. Affected units have specific lot numbers: 8442191-1 through 8443085-1 as listed in the recall notice.
Look for lot numbers 8442191-1 through 8443085-1 on the abutment packaging or product.
The screw stop ledge was not made to specification during manufacturing, causing the screw head to seat deeper in the abutment without a positive stop.
Check the lot numbers on the abutment: 8442191-1 through 8443085-1 as listed in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking lot numbers if you have the affected units.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-2141-2019 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-2141-2019 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.
