Class 2 Device Recall Solara Replacement Turbine

• Date Initiated by Firm: December 01, 2006
• Date Posted: December 27, 2006
• Recall Status: Terminated on June 12, 2007
• Recall Number: Z-0313-2007
• Recall Event ID: 36920
• 510(K)Number: K960507 K960719
• Product Classification: dental handpiece accessory - Product Code EFA
• Product: Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
• Code Information: Part number 064900, Lot numbers 1694789, 1697998, 1699566, and 1703516.0
• FEI Number: 2520265
• Recalling Firm/ Manufacturer: Stardental Division; 1816 Colonial Village Ln; Lancaster PA 17601-5891
• For Additional Information Contact: Kay Engle; 717-291-1161
• Manufacturer Reason for Recall: End cap component can disassemble.
• FDA Determined Cause: Other
• Action: The recalling firm sent recall letters to dealers and doctors via certified mail, return receipt on 12/6/06. Letters to the foreign accounts were sent via UPS or other traceable methods.
• Quantity in Commerce: 2756 end caps
• Distribution: Worldwide distribution, including USA, Canada and Japan.
• 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.

• 510(K) Database: 510(K)s with Product Code = EFA