Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0765-2013 · Posted 2013-02-01

Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeEKS
Date Initiated2012-12-12
Date Terminated2013-11-07
Product Quantity740 units

Reason for Recall

The length markings on the Lightspeed LSX files were wrong.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑