Events

Recall of Otto Bock Modular 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
    50486
  • Event Risk Class
    Class 2
  • Event Number
    Z-0537-2010
  • Event Initiated Date
    2008-10-28
  • Event Date Posted
    2009-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75488
  • 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
    External Limb Knee Joint Component - Product Code ISY
  • Reason
    Otto bock health care lp has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. this can cause the axes to gradually move out of the joint and result in a risk of falling for the user.
  • Action
    Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.

Device

Otto Bock Modular Knee Joint,
  • Model / Serial
    Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.
  • Product Description
    Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. || Pediatric Prosthetic Device used by Lower Limb amputees.
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • Manufacturer Address
    Bock,Otto,Orthopedic Ind,Inc, Two Carlson Parkway North, Suite 100, Minneapolis MN 55447
  • Source
    USFDA