FDAMarch 12, 2018device
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 temporomandibular joint. It is indi...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
This device was mislabeled and is not the correct component for this patient.
What to do
FDA enforcement status: Terminated
Brands named
tmj solutionstmj
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABARD Dynamic Tip Steerable, Product Number 6DYNTP001;2026-04-10
- FDADaig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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