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U.S. Department of Health and Human Services

Class 3 Device Recall Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair

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  Class 3 Device Recall Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair see related information
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/
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
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

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.