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U.S. Department of Health and Human Services

Class 2 Device Recall Posey

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 Class 2 Recall
Posey
see related information
Date Posted December 02, 2008
Recall Status1 Open
Recall Number Z-0286-2009
Recall Event ID 49498
Premarket Notification
510(K) Number
K963413 
Product Classification Restraint, Protective - Product Code FMQ
Product Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
Code Information Catalog Numbers: 2217SL and 2217B ; Note: All 22l7SL and 2217B units are affected by this recall.
Recalling Firm/
Manufacturer
J T Posey Company
5635 Peck Rd
Arcadia, California 91006
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Valerie Cimmarusti
626-454-2178
Manufacturer Reason
for Recall
Failure to restrain: This recall was initiated after a complaint was received by the firm regarding a Posey 2217SL unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. A second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a Posey 221 7SL unit
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action On July 29, 2008 Posey sent a Recall Letter to all affected customers. The recall letters were sent by certified mail with return receipt signature. The recall letter instructed the customers not to distribute or use the affected products. Any existing inventory subject to this recall was requested to be returned to Posey Company. Also, if they were a distributor, they were asked to please additionally forward a copy of the recall notice and reply form to each of their customers to whom you have further distributed the subject product. A Recall Fax Back form was provided with the recall letter for the affected facilities to fax back to inform Posey of their existing inventory. An RMA number was issured to each facility and a return UPS label was provided for any product that will be returned to Posey. Additionally, the sales representatives for each of the customers will be contacted by Posey Customer Service.
Quantity in Commerce 145 units
Distribution Worldwide, USA, Australia, Canada, France & The Netherlands.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMQ and Original Applicant = J. T. POSEY CO.
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