Multiple Limb Holders

• • Terminated Z-0934-2009 FDA Unclassified (pre-2012) ·initiated 8 Sep 2008

  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.

• • Terminated Z-0286-2009 FDA Unclassified (pre-2012) ·initiated 25 Jul 2008

  Failure to restrain: This recall was initiated after a complaint was received by the firm regarding a Posey 2217SL unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. A second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a Posey 221 7SL unit

510(k) Number

K963413 ↗

FDA Product Code

FMQ

Device Class

Class I

Regulation

21 CFR Part 880.6760

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Posey Bed

  Class I

  FDA 510(k) K113355 Active Cleared 2 May 2012

• Pediatric Limb Holders

  Class I

  FDA 510(k) K963439 Active Cleared 19 Nov 1996

• Posey Straight Jackets

  Class I

  FDA 510(k) K963410 Active Cleared 22 Nov 1996

• Jackets and Vests

  Class I

  FDA 510(k) K963442 Active Cleared 22 Nov 1996

• Restraint Accessories

  Class I

  FDA 510(k) K963436 Active Cleared 22 Nov 1996

• Pelvic Holders

  Class I

  FDA 510(k) K963437 Active Cleared 19 Nov 1996

See all devices from J. T. Posey Co. →