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 is recalling certain tin abutments 3.4mm (item ILDAN3) because a manufacturing defect causes screws to seat too deeply without stopping. This could damage dental implants during use.
During manufacturing, the screw stop ledge was not made to specification. This causes the screw head to seat deeper into the abutment without a positive stop, potentially damaging the implant.
Dental patients using Biomet 3i restorative products with the recalled abutments. Patients with implants in the maxilla or mandible are most at risk.
Check for item number ILDAN3 on the abutment. Affected units have specific lot numbers: 8442561-2, 8442561-3 with UDI codes starting with 0100844868031352.
Look for item number ILDAN3 and specific lot numbers on the abutment.
Biomet 3i recalls certain tin abutments 3.4mm (item ILDAN3) due to a manufacturing defect that can cause screws to seat too deeply without stopping.
Check for item number ILDAN3 and lot numbers 8442561-2 or 8442561-3 with UDI codes starting with 0100844868031352.
The recall does not specify a stop-use instruction, but the defect could damage implants, so check details before use.
We’ve drafted a message you can send Biomet 3i to request your refund or repair — edit it as you like.
Subject: Recall Z-2143-2019 — Biomet 3i Biomet 3i Hello, I own a Biomet 3i that is covered by recall Z-2143-2019 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.
