Events

Recall of Device Recall Otto Bock 3R90 and 3R92 Single Axis Knee Joint

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bock,Otto,Orthopedic Ind,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
    29670
  • Event Risk Class
    Class 2
  • Event Number
    Z-1379-04
  • Event Initiated Date
    2004-07-15
  • Event Date Posted
    2004-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34311
  • 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
    Component, External, Limb, Ankle/Foot - Product Code ISH
  • Reason
    Braking plates of the 3r90 and 3r92 modular knee joint with friction brake may become dislodged which may cause the braking performance of the knee to malfunction.
  • Action
    The braking plate of the knee may become dislodged, which may cause the braking performance of the knee to malfunction.

Device

Device Recall Otto Bock 3R90 and 3R92 Single Axis Knee Joint
  • Model / Serial
    No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Product Description
    Modular Knee Joint with Friction Brake
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • Manufacturer Address
    Bock,Otto,Orthopedic Ind,Inc, 3000 Xenium Ln N, Minneapolis MN 55441-2661
  • Source
    USFDA