TMJ Solutions recalls bilateral implants with incorrect patient-specific components that may cause right-sided open bite. Affected units have specific UDI-DI and lot numbers.
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
TMJ Solutions is recalling bilateral implants that may have incorrect patient-specific components, leading to a poor fit that causes a right-sided open bite. This could affect patients who received the implants during the specified production period.
The implant may have incorrect patient-specific components that cause a poor fit. This poor fit can lead to a right-sided open bite, where the jaw doesn't close properly on one side.
Patients who received the TMJ Bilateral Implants with the specific UDI-DI and lot numbers mentioned in the recall are most at risk. The recall targets individuals who had the implants manufactured between August 2023 and the current date.
Check for the UDI-DI number 07613327626575 and lot number 25081:181038 on the implant packaging or documentation. The recall applies to implants produced after August 2023.
Look for the UDI-DI number 07613327626575 and lot number 2508181038 on the implant packaging or documentation.
The implants may have incorrect patient-specific components that lead to a poor fit, causing a right-sided open bite.
Check for the UDI-DI number 07613327626575 and lot number 2508181038 on the implant packaging or documentation.
No immediate stop is required; check the details to see if your implants are affected.
We’ve drafted a message you can send TMJ Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-2524-2026 — TMJ Solutions TMJ Solutions Hello, I own a TMJ Solutions that is covered by recall Z-2524-2026 from TMJ Solutions. 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.
