| Class 2 Device Recall Lightspeed LSX Files | |
Date Initiated by Firm | December 12, 2012 |
Date Posted | February 01, 2013 |
Recall Status1 |
Terminated 3 on November 07, 2013 |
Recall Number | Z-0765-2013 |
Recall Event ID |
64163 |
Product Classification |
File pulp canal endodontic - Product Code EKS
|
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. |
Code Information |
Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204. |
Recalling Firm/ Manufacturer |
Ormco/Sybronendo 1332 S Lone Hill Ave Glendora CA 91740-5339
|
For Additional Information Contact | 909-962-5600 |
Manufacturer Reason for Recall | The length markings on the Lightspeed LSX files were wrong. |
FDA Determined Cause 2 | 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 in Commerce | 740 units |
Distribution | Worldwide Distribution - USA and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|