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
Intraoperative orthopedic joint assessment aid - Product Code ONN
원인
Presence of one inoperable (dead) sensor pad.
조치
OrthoSensor sent an Recall letter dated December 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Required Action for Users
" Remove the above-referenced serial numbers from your VERASENSE inventory and quarantine.
" Complete the enclosed Customer Response Form.
Actions to be taken by OrthoSensor
" You will be credited for these devices for your full purchase amount. The Returned Materials Authorization (RMA) number for each device in your possession is listed above.
" OrthoSensor will replenish these devices as soon as they are available.
For further questions please call (954) 577-7770.