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.
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.E., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
조치
Consignees were sent a Field Advisory Notice dated 5/22/2017 by mail informing them updated surgical techniques are available on Exactech's website (www.exac.com). The notice requested consignees:
Extend the information to accounts in possession of the product
Complete & return the attached Field Advisory Notice Response Form to Exactech
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