Recall Z-0765-2013— Ormco/Sybronendo
Class II · Terminated
Class II FDA medical device recall by Ormco/Sybronendo, initiated 2012-12-12, terminated 2013-11-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The length markings on the Lightspeed LSX files were wrong..
- Recalling firm
- Ormco/Sybronendo
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-12
- Terminated
- 2013-11-07
- Firm location
- Glendora, CA, United States
Product description
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.
Reason for recall
The length markings on the Lightspeed LSX files were wrong.
Data sourced from openFDA. This site is unofficial and independent of the FDA.