TMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled
TMJ Solutions Inc is recalling TMJ Bilateral Implants (REF: CHG020) because some units may contain incorrect patient-specific components, causing poor implant fit and right-sided open bite.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an implant with documented manufacturing defect (incorrect patient-specific components) that directly causes a clinical complication (right-sided open bite), classified as a risk-of-harm product where the potential for injury is established, though no reported illnesses or hospitalizations are mentioned in the source.
Plain-English summary
TMJ Solutions Inc is recalling TMJ Bilateral Implants, model CHG020 (UDI-DI: 07613327626575, Lot: 2508181038), distributed nationwide in Massachusetts. The implants may contain incorrect patient-specific components that can result in a poor fit of the implant.
This poor fit can lead to a right-sided open bite, a condition affecting normal jaw alignment and function. Patients who have received this implant should consult their healthcare provider about their individual situation and whether any clinical evaluation or intervention is needed.
The FDA has classified this as a Class II recall. Patients with questions or concerns should contact their healthcare provider or TMJ Solutions Inc.
The recalled product
- Product
- TMJ Bilateral Implants, REF: CHG020
- Manufacturer
- TMJ Solutions Inc
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 07613327626575
- Lot: 2508181038
Distribution
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