Device Recall Poly Component Trial, UCCS

  • Modelo / Serial
    Lot Numbers: a) REF 90-SRK-170310, TU53733-01 b) REF 90-SRK-170312, TU53736-01 c) REF 90-SRK-170314, TU53737-01 d) REF 90-SRK-170410, TU53733-02 e) REF 90-SRK-170412, TU53736-02 f) REF 90-SRK-170414, TU53737-02 g) REF 90-SRK-170510, TU53733-03 h) REF 90-SRK-170512, TU53736-03 i) REF 90-SRK-170514, TU53737-03 j) REF 90-SRK-170610, TU53733-04 k) REF 90-SRK-170612, TU53736-04 l) REF 90-SRK-170614, TU53737-04
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US distribution to AR, MA
  • Descripción del producto
    Poly Component Trial, UCCS, packaged in the following sizes and configurations: || a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 || b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 || c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 || d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 || e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 || f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 || g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 || h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 || i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514 || j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610 || k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612 || l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614 || 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
  • 1 Event


  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • Empresa matriz del fabricante (2017)
  • 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