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
Cement, dental - Product Code EMA
원인
The recall was initiated because pentron clinical has confirmed that the tempspan temporary cement may have black plastic material on the surface of the paste, and it may set faster than specified.
조치
Pentron Clinical sent an Urgent Medical Device Recall letter dated April 20, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete and fax back the enclosed recall form to 1-877-677-8844 in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer Service at (800) 551-0283, option 1, directly to handle the arrangements of a quick return and replacement.
For questions regarding this recall call 714-516-7400.
Worldwide Distribution - USA (nationwide) and the countries of Canada, Philippines, Italy, Netherlands, and the UK.
제품 설명
Brand Name: TempSpan CMT Temporary Cement, a temporary cement. || Part Number: N69CA. || The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.