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

FDA device recall Z-1311-2010 · posted 2010-04-09 · Terminated

Recall details

Recalling firm

Pelton & Crane Company

Reason for recall

The Dental Chair lacks a valid Device History Record.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KLC

Quantity affected

1 unit

Distribution

Nationwide distribution: NC

Date initiated

2010-02-09

Date posted

2010-04-09

Date terminated

2010-08-11

Location

Charlotte, NC