Date Initiated by Firm | April 20, 2009 |
Date Posted | September 22, 2009 |
Recall Status1 |
Terminated 3 on April 11, 2012 |
Recall Number | Z-2274-2009 |
Recall Event ID |
52711 |
510(K)Number | K963436 |
Product Classification |
Restraint, protective - Product Code FMQ
|
Product | Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed) (S27957).
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 S27957 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 |
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. |
Quantity in Commerce | 2 |
Distribution | Class II Recall - Worldwide Distribution -- United States, Canada, France, Belgium and the Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FMQ
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