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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
원인
Labeling error where three boxes in inventory had conflicting patient and primary labels. evaluation indicated that the primary label and patient label did not match. the primary label matched the label on the inner pouch, but the patient label was incorrect.
조치
Amendia Inc. sent an Urgent - Medical Device Recall letter dated November 22, 2016, to all affected customers.
The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand.
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