Events

Recall of Device Recall JTS External Drive Unit (JTS Grower Drive)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanmore Implants Worldwide Ltd..

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
    77753
  • Event Risk Class
    Class 2
  • Event Number
    Z-3104-2017
  • Event Initiated Date
    2017-07-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157829
  • 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, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Reason
    Three (3) complaints were identified in which the potential for utilization of the jts grower drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. as a result, the prostheses in such cases failed to extend as intended.
  • Action
    Stanmore Implants sent an Urgent Field Safety Notice dated July 4, 2017, notifying customers of the recall. Additionally, the recalling firm requests that consignees immediately check their inventory for recalled product, quarantine any product on hand, inform SIW of any product on hand, complete the attached response form, and return the response for and affected product to the firm. It is requested that consignees distribute the notice internally to all affected parties and that they contact their local Stanmore representative to request training. If any adverse events are associated with this device, the firm asks that it be reported to them. For further questions, please call (972) 501-1402.

Device

Device Recall JTS External Drive Unit (JTS Grower Drive)
  • Model / Serial
    Product Code MLE3; Serial No. 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 907-028, 907-237, 907-240, 907-500, 907-501, 907-502, 907-503, 907-504.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
  • Product Description
    JTS External Drive Unit || JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
  • Manufacturer
    Stanmore Implants Worldwide Ltd.

Manufacturer

Stanmore Implants Worldwide Ltd.
  • Manufacturer Address
    Stanmore Implants Worldwide Ltd., Centennial Park, 210 Centennial Avenue; CENTENNIAL PARK, Borehamwood United Kingdom
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA