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.
This recall has been terminated (originally issued February 1, 2013).
- Company
- Ormco/Sybronendo
- Recall Initiated
- December 12, 2012
- Posted
- February 1, 2013
- Terminated
- November 7, 2013
- Recall Number
- Z-0765-2013
- Quantity
- 740 units
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The length markings on the Lightspeed LSX files were wrong.
Distribution
Worldwide Distribution - USA and the country of Canada.
Lot / Code Info
Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204.
Root Cause
Process control
Action Taken
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.