Devices

Device Recall Poly Component Trial, UCCS

  • Model / 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
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution to AR, MA
  • Product Description
    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
    Medtronic Sofamor Danek USA Inc
  • 1 Event

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Manufacturer Address
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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