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.
A dimensional mismatch was identified which can potentially allow for interference between devices.
조치
Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Customers were instructed to immediately cease distribution or use of these products.
2. Extend this information to your accounts that may have this product in their possession.
3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots.
Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter.
For further questions please call (352) 377-1140.