TMJ Solutions recalls a specific TMJ reconstruction prosthesis component due to mislabeling. This incorrect part may not fit the patient's needs, risking improper use. Affected units include model TYY-NNNNRM with lot W43963 and serial T170939RM.
This device was mislabeled and is not the correct component for this patient.
TMJ Solutions is recalling a specific right mandibular component for TMJ reconstruction prostheses because it was mislabeled and may not be the correct part for the patient. Using this incorrect component could lead to improper fitting and potential complications.
The component was mislabeled and does not match the intended patient's needs. This could result in improper fitting during TMJ reconstruction, potentially causing discomfort or complications.
Patients who received the TMJ Reconstruction Prosthesis System with model TYY-NNNNRM, lot W43963, and serial T170939RM are affected. Those with TMJ reconstruction procedures using this specific component are most at risk.
Check for model TYY-NNNNRM, lot number W43963, and serial number T170939RM on the product. This component is part of the TMJ Reconstruction Prosthesis System.
Verify the model number, lot number, and serial number on the component to confirm if it matches TYY-NNNNRM, W43963, and T170939RM.
The correct model number is TYY-NNNNRM, as the recalled component was mislabeled and not the intended part.
The recall states the component is mislabeled and may not be the correct part, so it is not safe for use without verification.
Check for model TYY-NNNNRM, lot W43963, and serial T170939RM on the product label.
We’ve drafted a message you can send TMJ Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1444-2018 — TMJ Solutions TMJ Solutions Hello, I own a TMJ Solutions that is covered by recall Z-1444-2018 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.
