Date Initiated by Firm | February 20, 2012 |
Date Posted | March 06, 2012 |
Recall Status1 |
Terminated 3 on March 28, 2012 |
Recall Number | Z-1177-2012 |
Recall Event ID |
61262 |
510(K)Number | K946187 |
Product Classification |
Unit, operative dental - Product Code EIA
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Product | Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273
Product Usage:
The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up. |
Code Information |
Model #SET30, Catalog #3120, Serial numbers 4096 and 4099. |
Recalling Firm/ Manufacturer |
Pelton & Crane Company 11727 Fruehauf Dr Charlotte NC 28273
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For Additional Information Contact | Frank Ray 704-587-7227 |
Manufacturer Reason for Recall | Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up. |
FDA Determined Cause 2 | Employee error |
Action | Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope. |
Quantity in Commerce | 2 units |
Distribution | (USA) Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = EIA
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