Events

Recall of Device Recall Stride Femoral Component

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blue Belt Technologies MN.

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
    68482
  • Event Risk Class
    Class 2
  • Event Number
    Z-1943-2014
  • Event Initiated Date
    2014-06-04
  • Event Date Posted
    2014-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128025
  • 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, non-constrained, cemented, metal/polymer - Product Code HSX
  • Reason
    Mislabeled. packages labeled pfsi-00053, right lateral/left medial contains pfsi-00054, right medial/left lateral implants. packages labeled pfsi-00054, stride right medial/left lateral contain pfsi-00053, left medial/right lateral.
  • Action
    Firm initiated recall on 6/4/2014 by Blue Belt Technologies representatives hand delivering an Urgent Medeical Device Recall letter. The letter was addressed to the attention of Safety Officer/Regulatory Compliance Officer. The letter described the issue of the labeling mix-up, asked for devices to be quarantined, and stated that a Blue Belt Technologies Clinical Specialist will be contacting the consignee or return and replacement. A Receipt Acknowledgement form was asked to be returned by fax or mail.

Device

Device Recall Stride Femoral Component
  • Model / Serial
    Lot C785241, Exp 4-2015
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of CA, PA, and TX
  • Product Description
    Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
  • Manufacturer
    Blue Belt Technologies MN

Manufacturer

Blue Belt Technologies MN
  • Manufacturer Address
    Blue Belt Technologies MN, 2905 Northwest Blvd Ste 40, Plymouth MN 55441-2673
  • Source
    USFDA