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Terminated

Posey Connecting Strap/Belt, Polypropylene, 18" (235018). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

FDA Recall Z-2260-2009 · Posted 2009-09-22

Recalling FirmJ T Posey Company
Recall StatusTerminated
Product CodeFMQ
Date Initiated2009-04-20
Date Terminated2012-04-11
Product Quantity24

Reason for Recall

Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

Firm Action

JT Posey Company issued an "Urgent Medical Device Recall (Removal)" letter dated May 14, 2009 informing customers of the affected products. Any used and/or existing inventory subject to this recall is requested to be returned to Posey including the Recall Reply Fax-Back Form. For further questions, contact your local sales representative or JT Posey Company at 1-800-447-6739 extension 111.

Root Cause

Employee error

Distribution Pattern

Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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