Sybron recalls Legacy Smartbase dental implants with unapproved non-engaging abutments that lack FDA clearance. Consumers should contact Sybron for details on affected models and remedies.
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Sybron is recalling specific Legacy Smartbase dental implants because they were distributed without FDA clearance and their performance characteristics are not yet established. This could pose risks during dental procedures if the implants don't engage properly.
The recalled implants were distributed without FDA clearance, meaning they haven't been proven safe or effective for use. Their performance characteristics are not yet established, which could lead to improper engagement during dental procedures.
Dental patients who own or use the recalled Legacy Smartbase implants are affected. Patients using these implants for dental procedures are at higher risk due to potential improper engagement.
Check for the model names: Legacy Smartbase NE 3.0D 1MML, NE 3.0D 2MML, or Legacy Smartbase Narrow. Look for the reference codes: 8730-81NE, 8730-82NE, 8735-80NNE, 8735-82NE, 8745-80NNE, or 8745-82NE.
Reach out to Sybron directly to confirm if your specific Legacy Smartbase model is affected and get instructions on next steps.
The recall states these implants were distributed without FDA clearance and their performance characteristics are not yet established, so they are not considered safe for use.
Contact Sybron directly to determine if your specific model is affected and follow their instructions.
Check the model name and reference code on your implant. Affected models include Legacy Smartbase NE 3.0D 1MML (REF: 8730-81NE), NE 3.0D 2MML (REF: 8730-82NE), and others as listed in the recall notice.
We’ve drafted a message you can send Sybron to request your refund or repair — edit it as you like.
Subject: Recall Z-2037-2023 — Sybron Sybron Hello, I own a Sybron that is covered by recall Z-2037-2023 from Sybron. 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.