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
Plastic Surgery And Accessories Kit - Product Code FTN
원인
Device was distributed without the dome part accessory, part number 350-dompk.
조치
The recall letters for Lot 269402 were sent on 12/16/2003. The recall letters for Lot 264358 were sent on 02/06/2004. Each letter included 5 dome pack accessories as a temporary corrective action.
Nationwide. Recalled product was shipped domestically to accounts in AZ, AR, CA, GA, IL, IN, KY, MD, MI, OH, OK, OR, TX, and NY. There was no foreign distribution.