Biomet 3i recalls certain tin abutments 3.4mm (item IEDAN3) due to manufacturing defect causing screw to seat deeper without 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 specific tin abutments (3.4mm, item IEDAN3) because a manufacturing defect causes the screw to seat deeper without a positive stop. This could lead to improper screw placement during dental implant procedures.
The screw stop ledge was not made to specification during manufacturing, causing the screw head to seat deeper into the abutment without a positive stop. This could lead to improper screw placement during dental implant procedures.
Dental professionals using Biomet 3i restorative products for dental implants are affected. Patients receiving these implants may be at risk if the abutment is used incorrectly.
Check for lot numbers 8442784-1, 8442469-1, or 8442689-1 on the product packaging. The product is a 3.4mm tin abutment with item number IEDAN3.
Look for lot numbers 8442784-1, 8442469-1, or 8442689-1 on the abutment packaging.
The screw stop ledge was not made to specification during manufacturing, causing the screw head to seat deeper into the abutment without a positive stop.
Check the lot number on the packaging. If it matches 8442784-1, 8442469-1, or 8442689-1, stop using it and contact Biomet 3i for further instructions.
The recall record does not mention a remedy or fix for this defect.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-2140-2019 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-2140-2019 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.
