Z-0934-2009

Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing...

Name: Z-0934-2009 Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing...
Creator: J T Posey Company
Published: 2008-09-08
License: https://open.fda.gov/license/

J. T. Posey Co. / initiated 2008-09-08 / Terminated

FDA source

J T Posey Company began a recall of 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 on 2008-09-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0934-2009
Status: Terminated
Initiated: 2008-09-08
Posted: 2009-02-03
Terminated: 2012-04-16
Recalling firm: J. T. Posey Co.
Product: 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.
Product code: FMQ Restraint, Protective
Reason for recall: 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.
FDA root cause: Other
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 ([email protected]) within 7 days. Contact your Sales Representative with any questions or concerns.
Quantity in commerce: 51,200 (Approximately)
Distribution: Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.
Product codes and lots: Catalog Numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213.

Product code FMQ

K963413Class IMultiple Limb HoldersJ. T. Posey Co. / cleared 1996-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)