U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
File pulp canal endodontic - Product Code EKS
원인
The length markings on the lightspeed lsx files were wrong.
조치
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.
Worldwide Distribution - USA and the country of Canada.
제품 설명
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.