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
Soft Tissue Fixation Fastener - Product Code MBI
원인
Product package may crack and cause loss of sterility.
조치
Stryker Endoscopy initiated the recall on 02/07/2008 by notifying its consignees via telephone, as well as sending out Urgent: Device Removal notices. Recipients of affected lots are to inspect their inventory for part/lot numbers and quarantine any affected product. Affected products are to be returned to Stryker Endoscopy and Customer Service should be contacted for replacement alternatives. Also, the "Acknowledgment of recipt" card needs to be signed and returned to Stryker Endoscopy.
Product was distributed to 8 consignees in CA, OH, PA, CO, MA, and NJ.
제품 설명
Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135. || Intended for use in securing soft tissue to bone in certain procedures in specific areas.