Events

Recall of Device Recall Poly Component Trial, CR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek USA Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76694
  • Event Risk Class
    Class 2
  • Event Number
    Z-1515-2017
  • Event Initiated Date
    2017-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153924
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
  • Action
    Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.

Device

Device Recall Poly Component Trial, CR
  • Model / Serial
    Lot Numbers: a) REF 90-SRK-160310, TU53730-01 b) REF 90-SRK-160312, TU53731-01 c) REF 90-SRK-160314, TU53732-01 d) REF 90-SRK-160410, TU53730-02 e) REF 90-SRK-160412, TU53731-02 f) REF 90-SRK-160414, TU53732-02 g) REF 90-SRK-160510, TU53730-03 h) REF 90-SRK-160512, TU53731-03 i) REF 90-SRK-160514, TU53732-03 j) REF 90-SRK-160610, TU53730-04 k) REF 90-SRK-160612, TU53731-04 l) REF 90-SRK-160614, TU53732-04
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US distribution to AR, MA
  • Product Description
    Poly Component Trial, CR, packaged in the following sizes and configurations: || a) Poly Component Trial - CR 3x10, REF 90-SRK-160310 || b) Poly Component Trial - CR 3x12, REF 90-SRK-160312 || c) Poly Component Trial - CR 3x14, REF 90-SRK-160314 || d) Poly Component Trial - CR 4x10, REF 90-SRK-160410 || e) Poly Component Trial - CR 4x12, REF 90-SRK-160412 || f) Poly Component Trial - CR 4x14, REF 90-SRK-160414 || g) Poly Component Trial - CR 5x10,REF 90-SRK-160510 || h) Poly Component Trial - CR 5x12, REF 90-SRK-160512 || i) Poly Component Trial - CR 5x14, REF 90-SRK-160514 || j) Poly Component Trial - CR 6x10, REF 90-SRK-160610 || k) Poly Component Trial - CR 6x12, REF 90-SRK-160612 || l) Poly Component Trial - CR 6x14, REF 90-SRK-160614 || 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

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