Events

Recall of Posey Swedish Belt

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by J T Posey Company.

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
    52711
  • Event Risk Class
    Class 2
  • Event Number
    Z-2275-2009
  • Event Initiated Date
    2009-04-20
  • Event Date Posted
    2009-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83781
  • 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
    Restraint, protective - Product Code FMQ
  • Reason
    Posey has initiated a recall on certain posey product units which were manufactured using an incorrect key lock buckle. the intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
  • Action
    JT Posey Company issued an "Urgent Medical Device Recall (Removal)" letter dated May 14, 2009 informing customers of the affected products. Any used and/or existing inventory subject to this recall is requested to be returned to Posey including the Recall Reply Fax-Back Form. For further questions, contact your local sales representative or JT Posey Company at 1-800-447-6739 extension 111.

Device

Posey Swedish Belt
  • Model / Serial
    All Product with Catalog Number 1337 manufactured between Ferbruary 2009 and April 2009.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.
  • Product Description
    Posey Swedish Belt (1337). || Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
  • Manufacturer
    J T Posey Company

Manufacturer

J T Posey Company
  • Manufacturer Address
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006
  • Manufacturer Parent Company (2017)
    Tidi Products Llc
  • Source
    USFDA