Recall Z-0765-2013 ยท EKS File, Pulp Canal, Endodontic
Ormco/Sybronendo
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.
| Date | Feb 1, 2013 (initiated Dec 12, 2012) |
| Status | Terminated |
| Reason | The length markings on the Lightspeed LSX files were wrong. |
| Root cause | Process control |
| 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. |
| Quantity | 740 units |
| Distribution | Worldwide Distribution - USA and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.