Recall of Device Recall ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthosensor, 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
    69963
  • Event Risk Class
    Class 2
  • Event Number
    Z-1029-2015
  • Event Initiated Date
    2014-12-05
  • Event Date Posted
    2015-01-29
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-03-13
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Intraoperative orthopedic joint assessment aid - Product Code ONN
  • Reason
    Presence of one inoperable (dead) sensor pad.
  • Action
    OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users " Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine. " Complete the enclosed Customer Response Form. Actions to be taken by OrthoSensor " You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above. " OrthoSensor will replenish these devices as soon as they are available. For further questions please call (954) 577-7770.

Device

  • Model / Serial
    Model SYK-TRCR 02, Lot # 091914V11770, Serial #s: 411654008, 411585023, 411654007, 411585032, 411585014, 411654016, 411585017, 411654015, 411585030, 411654020, 411654004, 411654010, 411585007, 411585005, 411654011, 411585036, 411585035, 411654018, 411654012, 411585011, 411654014, 411654005, 411654001, 411585003.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : IL, MI, NY, CA, VA and NV.
  • Product Description
    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Orthosensor, Inc., 1560 Sawgrass Corporate Pkwy, 4th Floor, Sunrise FL 33323-2858
  • Manufacturer Parent Company (2017)
  • Source
    USFDA