Z-0286-2009

Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B

Name: Z-0286-2009 Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
Creator: J T Posey Company
Published: 2008-07-25
License: https://open.fda.gov/license/

J. T. Posey Co. / initiated 2008-07-25 / Terminated / root cause: design

FDA source

J T Posey Company began a recall of Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B on 2008-07-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0286-2009
Status: Terminated
Initiated: 2008-07-25
Posted: 2008-12-02
Terminated: 2012-03-30
Recalling firm: J. T. Posey Co.
Product: Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
Product code: FMQ Restraint, Protective
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: On July 29, 2008 Posey sent a Recall Letter to all affected customers. The recall letters were sent by certified mail with return receipt signature. The recall letter instructed the customers not to distribute or use the affected products. Any existing inventory subject to this recall was requested to be returned to Posey Company. Also, if they were a distributor, they were asked to please additionally forward a copy of the recall notice and reply form to each of their customers to whom you have further distributed the subject product. A Recall Fax Back form was provided with the recall letter for the affected facilities to fax back to inform Posey of their existing inventory. An RMA number was issured to each facility and a return UPS label was provided for any product that will be returned to Posey. Additionally, the sales representatives for each of the customers will be contacted by Posey Customer Service.
Quantity in commerce: 145 units
Distribution: Worldwide, USA, Australia, Canada, France & The Netherlands.
Product codes and lots: Catalog Numbers: 2217SL and 2217B ; Note: All 22l7SL and 2217B units are affected by this recall.

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)