Data Foundry

Medical device recalls 2013

Posey Biothane Restraint Cuffs — Class II medical device recall Z-1071-2013

Terminated recall by J T Posey Company, reported 2013-04-17, distributed nationwide. The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required speci

Recall numberZ-1071-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmJ T Posey Company, Arcadia, CA, United States
Recall initiated2012-10-31
Classified2013-04-09
Reported by FDA2013-04-17
Terminated2014-07-17
DistributedNationwide (US)
Quantity1,673 units
Reason classespotency
Model numbers2900

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1071-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.