Sybron Endo Lightspeed LSX Files Recalled for Incorrect Length Markings
Ormco/Sybronendo is recalling specific lots of Lightspeed LSX endodontic files because their length markings are incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect length markings on a medical device. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Ormco/Sybronendo is recalling specific lots of Sybron Endo Lightspeed LSX rotary endodontic files. The affected products include LSX Files, 25MM (Part Number 835-2525), LSX Files, 25MM Assorted Kit (Part Number 835-2455), and LSX Files, 30MM (Part Number 835-2031). A total of 740 units are involved in this recall.
The recall was initiated because the length markings on the Lightspeed LSX files were wrong. These instruments are engine-driven rotary endodontic instruments used during endodontic procedures for cleaning and shaping the root canal.
The affected products were distributed worldwide, specifically in the United States and Canada. Healthcare professionals and patients should stop using the affected files and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Ormco/Sybronendo
- Hazard
- Affected units
- 740
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Part # 835-2525
- Lot # 091274189. Part # 835-2455
- Lot # 091272054
- 091279295
- 101200609
- 101200610
- 101200612. Part # 835-2031
- Lot # 091268204.
Distribution
Distribution scope not specified by the agency.
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