Z-1071-2013Class II

Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to...

Name: Z-1071-2013 Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to...
Creator: J T Posey Company
Published: 2012-10-31
License: https://open.fda.gov/license/

J. T. Posey Co. / initiated 2012-10-31 / Terminated / root cause: manufacturing process

FDA source

J T Posey Company began a recall of Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection... on 2012-10-31. FDA classified it as Class II and gives the reason as "The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1071-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-31
Posted: 2013-04-09
Terminated: 2014-07-17
Recalling firm: J. T. Posey Co.
Product: Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
Product code: FMQ Restraint, Protective
Reason for recall: The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: J. T. Posey sent an Medical Device Recall (Removal) letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customer that Posey Company is voluntarily recalling all units of Posey BiothaneQD Cuffs, Catalog Number 2900. All lots of this product are being recalled. Reason for recall was listed:"Posey has identified rivets on the Biothane~ Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb. No patient injuries or deaths have reported." Please immediately discontinue further distribution or use of Posey Biothane~ Cuffs, Catalog Number 2900. Please Complete and return the Acknowledgement and Receipt Form to Posey within 7 days using the provided self-addressed, stamped envelope, by fax to 626-443-5418 or via e-mail to [email protected]. Return this form even if you do not have any devices in your facility. Please return directly to Posey ill! units you have of Biothane~ Cuffs, Catalog Number 2900, using the enclosed pre-paid shipping label containing an RMA number. Posey will provide replacement product or credit upon receipt of the product. If you have any further questions please call (626) 443-3143.
Quantity in commerce: 1673 units
Distribution: Nationwide Distribution
Product codes and lots: The model/catalog number for the device is 2900. All lots are being recalled.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-09

Product code FMQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)