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U.S. Department of Health and Human Services

Class 2 Device Recall Posey Locking TwiceAs Tough Cuffs

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 Class 2 Device Recall Posey Locking TwiceAs Tough Cuffssee related information
Date Initiated by FirmApril 20, 2009
Date PostedSeptember 22, 2009
Recall Status1 Terminated 3 on April 11, 2012
Recall NumberZ-2270-2009
Recall Event ID 52711
510(K)NumberK963436 
Product Classification Restraint, protective - Product Code FMQ
ProductPosey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
Code Information All Product with Catalog Number 2798 manufactured between Ferbruary 2009 and April 2009.
Recalling Firm/
Manufacturer		 J T Posey Company
5635 Peck Rd
Arcadia CA 91006
For Additional Information Contact
626-443-3143
Manufacturer 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.
FDA Determined
Cause 2		Employee error
ActionJT 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.
Quantity in Commerce446
DistributionClass II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMQ
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