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Terminated

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

FDA Recall Z-1311-2010 · Posted 2010-04-09

Recalling FirmPelton & Crane Company
Recall StatusTerminated
Product CodeKLC
Date Initiated2010-02-09
Date Terminated2010-08-11
Product Quantity1 unit

Reason for Recall

The Dental Chair lacks a valid Device History Record.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide distribution: NC

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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