Recall Z-1071-2013— J T Posey Company
Class II · Terminated
Class II FDA medical device recall by J T Posey Company, initiated 2012-10-31, terminated 2014-07-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- J T Posey Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-31
- Terminated
- 2014-07-17
- Firm location
- Arcadia, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.