FDA-Device2026-07-01Class IIPROCESSING DEFECT
TMJ Solutions temporomandibular joint implant recalled for incorrect patient-specific components
What this means
TMJ Solutions Inc. has recalled one custom temporomandibular joint implant (model CHG020) that may contain incorrect patient-specific components. The mismatch caused a poor fit, resulting in a right-sided open bite for the affected patient.
- If you received this implant, contact your surgeon immediately to discuss your symptoms and next steps.
- Do not attempt to adjust or remove the implant yourself.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of MA.
Affected count
1
Manufactured in
6059 King Dr, N/A, Ventura, CA, United States
Products
TMJ Bilateral Implants, REF: CHG020
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2524-2026Want us to check the next one for you?
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