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U.S. Department of Health and Human Services

Class 2 Device Recall Lightspeed LSX Files

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 Class 2 Recall
Lightspeed LSX Files
see related information
Date Posted February 01, 2013
Recall Status1 Terminated on November 07, 2013
Recall Number Z-0765-2013
Recall Event ID 64163
Product Classification File, Pulp Canal, Endodontic - Product Code EKS
Product Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.
Code Information Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.
Recalling Firm/
Manufacturer
Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora, California 91740-5339
Manufacturer Reason
for Recall
The length markings on the Lightspeed LSX files were wrong.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Sybron Endo sent a Urgent: Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has come to our attention that the length rings laser-etched on several lots of the Lightspeed LSX Files are inaccurate. We are asking for the product to be returned since use of the file could be a safety risk due to misadjustment of the file length. Please contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement.
Quantity in Commerce 740 units
Distribution Worldwide Distribution - USA and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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