Reported Feb 13, 2013 · Terminated
Sybron Endo Lightspeed
Ormco/Sybronendo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ormco/Sybronendo · 1332 S Lone Hill Ave · Glendora, CA · 91740-5339
Is this the product you have?
Sybron Endo Lightspeed
3 of 3 products
| # | Product as published |
|---|---|
| 1 | LSX Files, 25MM, Part Numbers: 835-2525 |
| 2 | LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455 |
| 3 | LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. |
- Lot codes and dates
Part # 835-2525Lot # 091274189. Part # 835-2455Lot # 091272054091279295101200609101200610101200612. Part # 835-2031Lot # 091268204
- Amount recalled
- 740 units
Why it was recalled
The length markings on the Lightspeed LSX files were wrong.
This product could cause temporary or reversible health problems — stop using it.
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