J T Posey Company 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.