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
Motor, surgical instrument, pneumatic powered - Product Code GET
원인
Certain lots of the aesculap hi line xxs handpiece (part # gb790r) were recalled due to a possible failure of the handpiece.
조치
Aesculap sent an Important Correction & Removal Notification letter dated December 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine all affected product and returned to AIC (USA). Customers were instructed that a Aesculap Sales Representative would contact them to schedule return of any affected inventory and replace their product. Customers were asked to complete the inventory sheet with the quantity being returned. If customers could not locate the product, they were to provide an explanation as to why the inventory would not be returned (discarded, etc.). Customers with questions were instructed to call 610-984-9414,
For questions regarding this recall call 800-258-1946, ext 5067.
Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.
제품 설명
Aesculap Hi-Line XXS handpiece || Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.