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U.S. Department of Health and Human Services

Class 2 Device Recall Pelton & Crane Spirit 3000

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  Class 2 Device Recall Pelton & Crane Spirit 3000 see related information
Date Initiated by Firm March 04, 2011
Date Posted March 30, 2011
Recall Status1 Terminated 3 on August 16, 2011
Recall Number Z-1850-2011
Recall Event ID 58105
Product Classification dental chair - Product Code NRU
Product Pelton & Crane Spirit 3000 dental chair (Model #SP30)
Code Information Agency model #SP30, Catalog model #3003 and 3004, all units
Recalling Firm/
Pelton & Crane Company
11727 Fruehauf Dr
Charlotte NC 28273
For Additional Information Contact Mr. Frank Ray
704-588-2126 Ext. 227
Manufacturer Reason
for Recall
The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.
FDA Determined
Cause 2
Process control
Action Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.
Quantity in Commerce 9 units
Distribution Distribution to USA, Canada, and the Netherlands.
Total Product Life Cycle TPLC Device Report

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.