Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; L
FDA device recall Z-0765-2013 · posted 2013-02-01 · Terminated
Recall details
- Recalling firm
- Ormco/Sybronendo
- Reason for recall
- The length markings on the Lightspeed LSX files were wrong.
- Action taken
- 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
- Status
- Terminated
- Product code
- EKS
- Quantity affected
- 740 units
- Distribution
- Worldwide Distribution - USA and the country of Canada.
- Date initiated
- 2012-12-12
- Date posted
- 2013-02-01
- Date terminated
- 2013-11-07
- Location
- Glendora, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.