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.
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 2/5 (Moderate).
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…
- 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:
Related recalls
Same manufacturer · TMJ Solutions Inc
See all →- HighTMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled
FDA (Devices) · 2026-07-01
- CriticalJaw joint implants recalled over a discrepancy in screw hole position
FDA (Devices) · 2025-11-26
- HighStryker TMJ Unilateral Implant Recalled Due to Incorrect Components
FDA (Devices) · 2024-10-02
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- HighStryker TMJ Unilateral Implant Recalled Due to Incorrect Components
FDA (Devices) · 2024-10-02
- ModerateBiomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up
FDA (Devices) · 2014-09-10
- HighTMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled
FDA (Devices) · 2026-07-01
- HighTMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
FDA (Devices) · 2023-03-15
- CriticalJaw joint implants recalled over a discrepancy in screw hole position
FDA (Devices) · 2025-11-26
- ModerateBiomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems
FDA (Devices) · 2014-12-17