Devices

Device Recall Poly Component Trial, MPCS

  • Modelo / Serial
    Lot Numbers:  a) REF 90-SRK-192310, TU53744-01 b) REF 90-SRK-191310, TU53741-01 c) REF 90-SRK-192312, TU53745-01 d) REF 90-SRK-191312, TU53742-01 e) REF 90-SRK-192314, TU53746-01 f) REF 90-SRK-191314, TU53743-01 g) REF 90-SRK-192410, TU53744-02 h) REF 90-SRK-191410, TU53741-02 i) REF 90-SRK-192412, TU53745-02 j) REF 90-SRK-191412, TU53742-02 k) REF 90-SRK-192414, TU53746-02 l) REF 90-SRK-191414, TU53743-02 m) REF 90-SRK-192510, TU53744-03 n) REF 90-SRK-191510, TU53741-03 o) REF 90-SRK-192512, TU53745-03 p) REF 90-SRK-191512, TU53742-03 q) REF 90-SRK-192514, TU53746-03 r) REF 90-SRK-191514, TU53743-03 s) REF 90-SRK-192610, TU53744-04 t) REF 90-SRK-191610, TU53741-04 u) REF 90-SRK-192612, TU53745-04 v) REF 90-SRK-191612, TU53742-04 w) REF 90-SRK-192614, TU53746-04 x) REF 90-SRK-191614, TU53743-04
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US distribution to AR, MA
  • Descripción del producto
    Poly Component Trial, MPCS, packaged in the following sizes and configurations: || a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 || b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 || c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 || d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 || e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314 || f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314 || g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410 || h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410 || i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412 || j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412 || k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414 || l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414 || m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510 || n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510 || o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512 || p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512 || q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514 || r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514 || s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610 || t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610 || u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612 || v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612 || w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614 || x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614 || The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc
  • 1 Event

Fabricante

Medtronic Sofamor Danek USA Inc
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA