Events

Recall of Device Recall TENET Wrist Stabilization Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tenet Medical Engineering 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
    46158
  • Event Risk Class
    Class 2
  • Event Number
    Z-0579-2008
  • Event Initiated Date
    2007-11-23
  • Event Date Posted
    2008-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66910
  • 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
    surgical wrist stabilizer - Product Code JEB
  • Reason
    Sterility compromised: sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
  • Action
    TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product.

Device

Device Recall TENET Wrist Stabilization Kit
  • Model / Serial
    Lot Number: 20060605.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
  • Manufacturer
    Tenet Medical Engineering Inc

Manufacturer

Tenet Medical Engineering Inc
  • Manufacturer Address
    Tenet Medical Engineering Inc, 11979 40th St Se /#203 Ab, Calgary Canada
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA