Events

Recall of Posey Connecting Straps & Belts/Locking Cuffs.

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
    50134
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-2009
  • Event Initiated Date
    2008-09-08
  • Event Date Posted
    2009-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74796
  • 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
    The recall was initiated after an investigation conducted by the posey company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. in some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver.
  • Action
    An "Urgent Medical Device Recall (Correction)" letter dated August 15, 2008 was mailed via US Postal Service to affected customers. The letter described the issue, instructed customers to secure a replacement label with the correct application technique over the picture in the 2008 Posey Catalog and provided a corrected Posey Locking Cuffs Instruction Sheet (19273). The Posey Company also provided updated literature for the Posey Locking and Non-Locking Connecting Straps 19270 and 19254. The Posey Company asked customers to complete and return the "Reply Fax-Back Acknowledgment" Form via fax (626-443-5418) or e-mail (vcimmarusti@posey.com) within 7 days. Contact your Sales Representative with any questions or concerns.

Device

Posey Connecting Straps & Belts/Locking Cuffs.
  • Model / Serial
    Catalog Numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.
  • Product Description
    Posey Connecting Straps & Belts/Locking Cuffs. || The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt.
  • 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