TMJ Solutions Recalls Misidentified Right Mandibular Component
TMJ Solutions Inc is recalling a specific right mandibular component of a TMJ Reconstruction Prosthesis System because it was mislabeled and is not the correct component for the intended patient.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as a labeling error where the device is not the correct component for the patient. No injuries or illnesses are reported, fitting the criteria for a moderate severity labeling error.
Plain-English summary
TMJ Solutions Inc is recalling one unit of the Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component, part of the TMJ Reconstruction Prosthesis System. The specific unit is identified by Lot W43963 and Serial T170939RM. The device was distributed to Georgia.
The recall was initiated because the device was mislabeled and is not the correct component for the patient for whom it was intended. The TMJ Reconstruction Prosthesis System is generally indicated for the reconstruction of the temporomandibular joint in patients with specific conditions, such as inflammatory arthritis or recurrent ankylosis, that are not responsive to other treatments.
Patients who have received this specific component should contact their healthcare provider or TMJ Solutions Inc for further instructions. The recall is limited to the single unit identified by the specific lot and serial numbers provided.
The recalled product
- Product
- Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibu
- Manufacturer
- TMJ Solutions Inc
- Hazard
- 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 (3)
- Lot: W43963
- Serial T170939RM
- UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF
Distribution
Distributed in 1 state:
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