Sybron Endo Lightspeed: LSX Files — Class II medical device recall Z-0765-2013
Terminated recall by Ormco/Sybronendo, reported 2013-02-13. The length markings on the Lightspeed LSX files were wrong.
| Recall number | Z-0765-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2012-12-12 |
| Classified | 2013-02-01 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2013-11-07 |
| Countries outside the US | CA |
| Quantity | 740 units |
| Lot numbers | 091268204, 091272054, 091274189, 091279295, 101200609, 101200610, 101200612 |
| Model numbers | 835-2031, 835-2455, 835-2525 |
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 for recall
The length markings on the Lightspeed LSX files were wrong.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0765-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.