Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1311-2010

Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients...

KaVo Dental Technologies, LLC / initiated 2010-02-09 / Terminated

Pelton & Crane Company began a recall of Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures on . The reason FDA records is "The Dental Chair lacks a valid Device History Record". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1311-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KaVo Dental Technologies, LLC
Product
Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.
Product code
KLC Chair, Dental, With Operative Unit
Reason for recall
The Dental Chair lacks a valid Device History Record.
FDA root cause
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
Product codes and lots
Catalog number: 3003, Model number: SP30, Chair Serial #14736