Recall Z-1311-2010 ยท KLC Chair, Dental, With Operative Unit
Pelton & Crane Company
Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.
| Date | Apr 9, 2010 (initiated Feb 9, 2010) |
| Status | Terminated |
| Reason | The Dental Chair lacks a valid Device History Record. |
| 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- |
| Quantity | 1 unit |
| Distribution | Nationwide distribution: NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.