HIGHFDA DEVICE

TMJ Bilateral Implants, REF: CHG020

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 SolutionsHealth & Personal CareMedical DevicesUDI-DI: 07613327626575Lot: 2508181038

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 11, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
February 11, 2026
Hazard Level
HIGH
Brand
TMJ Solutions
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
TMJ Solutions
Model numbers
UDI-DI: 07613327626575, Lot: 2508181038
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 11, 2026

  2. Reported by FDA DEVICE

    July 1, 2026

  3. RecallRadar source check

    July 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact TMJ Solutions Inc or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

TMJ Bilateral Implants, REF: CHG020. Reason: 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.. Classification: Class II. Quantity: 1. Distribution: US Nationwide distribution in the state of MA.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: 07613327626575
Lot: 2508181038
Affected States
ALL
Report Date
July 1, 2026
Recall Status
ACTIVE