Biomet recalls certain Healing Abutments due to potential 30-degree rotation error affecting dental implants. Affected units have specific dimensions and lot numbers.
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Biomet is recalling specific Healing Abutments that may cause dental implants to rotate incorrectly by up to 30 degrees. This could lead to misalignment of the implant margin, potentially affecting the fit and function of the dental restoration.
The Healing Abutment may produce scanned data that rotates the implant by about 30 degrees or misaligns the margin contour. This could cause improper fit and function of the dental restoration, potentially requiring additional procedures to correct.
Dental patients who have received the specific Healing Abutment model with dimensions 3.4mm x 3.8mm x 6mm and lot number 1228247 are affected. Patients with dental implants using this product are most at risk.
Check if your Healing Abutment has dimensions 3.4mm (diameter) x 3.8mm (width) x 6mm (height) and lot number 1228247. The reference number is IEHA346.
Verify your Healing Abutment's dimensions and lot number to confirm if it is affected.
The recall involves a potential 30-degree rotation error that could affect implant fit, but it does not pose an immediate risk of injury or serious harm. The hazard is low risk.
Check if your Healing Abutment has dimensions 3.4mm x 3.8mm x 6mm and lot number 1228247. The reference number is IEHA346.
The recall does not specify a remedy, so you should check with your dentist to determine if any action is needed.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1368-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1368-2020 from Biomet. 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.
