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
Dental Cement - Product Code EMA
원인
Low bonding performance: the affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured).
조치
A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand
Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.
제품 설명
TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637