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
Lavage, jet - Product Code FQH
원인
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
조치
Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.
Worldwide Distribution -- United States, Canada and Japan.
제품 설명
Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile, Zimmer, Dover, Ohio; Catatog Number: 00515018300. || Used in conjunction with the Pulsavac Plus Wound Debridement System for pulsatile lavage/debridement.