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
Calcium salt bone void filler, drillable, non-screw augmentation - Product Code OIS
원인
The contract supplier notified depuy synthes on june 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. some kit expiration dates were later than the earliest expiration date of the component lots. the expiration dates of some components are earlier than that listed on the kit.
조치
On August 15, 2017 an Urgent Medical Device Recall notice, titled "895204 NORIAN DRILLABLE INJECT" was issued to customers instructing them to review inventory and quarantine all affected product subject to the recall. For questions. concerns or to obtain a return authorization Call 1-800-479-6329. Returned product will be credited.