Biomet recalls certain Healing Abutments (IEHA354) due to potential 30-degree rotation error affecting dental implants. Affected lots: 1228687, 1229554, 12295: 1229555.
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 improper alignment and affect the implant's success.
The recalled Healing Abutments may produce scanned data that rotates the implant by about 30 degrees. This misalignment could cause the implant to be improperly positioned, potentially affecting its long-term success.
Dental patients who received the recalled Healing Abutments (lot numbers 1228687, 1229554, 1229555) are affected. Patients with dental implants using these specific abutments are most at risk.
Check your Healing Abutment's lot number: 1228687, 1229554, or 1229555. The product is a 3.4mm diameter x 5mm length x 4mm height implant.
Verify your Healing Abutment's lot number to see if it matches 1228687, 1229554, or 1229555.
The recalled Healing Abutments may cause dental implants to rotate incorrectly by about 30 degrees, leading to margin contour misalignment.
Check the lot number on your Healing Abutment; affected lots are 1228687, 1229554, or 1229555.
The recall does not specify a remedy, so contact Biomet directly for guidance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1370-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1370-2020 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.