Date Initiated by Firm |
February 09, 2010 |
Date Posted |
April 09, 2010 |
Recall Status1 |
Terminated 3 on August 11, 2010 |
Recall Number |
Z-1311-2010 |
Recall Event ID |
54809 |
Product Classification |
Spirit 3000 dental chair - Product Code KLC
|
Product |
Pelton & Crane Spirit 3000 Dental Chair.
The intended use of this device is for properly positioning patients to perform dental procedures.
|
Code Information |
Catalog number: 3003, Model number: SP30, Chair Serial #14736 |
Recalling Firm/ Manufacturer |
Pelton & Crane Company 11727 Fruehauf Dr Charlotte NC 28273
|
For Additional Information Contact |
Mr. Frank Ray 704-588-2126 Ext. 227
|
Manufacturer Reason for Recall |
The Dental Chair lacks a valid Device History Record.
|
FDA Determined Cause 2 |
Other |
Action |
An "URGENT MEDICAL DEVICE RECALL" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA.
Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored. |
Quantity in Commerce |
1 unit |
Distribution |
Nationwide distribution: NC |
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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