Posey Swedish Belt (1337). 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-2275-2009 · Posted 2009-09-22
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Recalling FirmJ T Posey Company
Recall StatusTerminated
Product CodeFMQ
Date Initiated2009-04-20
Date Terminated2012-04-11
Product Quantity659
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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