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U.S. Department of Health and Human Services

Class 2 Device Recall Posey

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  Class 2 Device Recall Posey see related information
Date Initiated by Firm July 25, 2008
Date Posted December 02, 2008
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-0286-2009
Recall Event ID 49498
510(K)Number K963413  
Product Classification restraint - 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 CA 91006
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		 Device Design
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 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) Database 510(K)s with Product Code = FMQ and Original Applicant = J. T. POSEY CO.
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