Device Recall TMJ Concepts PatientFitted TMJ Reconstruction Prosthesis System

  • Model / Serial
    Lot: W43963, Serial T170939RM, UDI +B004TYYNNNNRM0/$$3191101W43963/ST170939RMF
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution to GA.
  • Product Description
    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 indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    TMJ Solutions Inc, 2233 Knoll Dr, Ventura CA 93003-7398
  • Manufacturer Parent Company (2017)
  • Source
    USFDA