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.
Devices were inadvertently sent to packaging and finished goods prior to the pma site-change supplement approval.
조치
Customers were notified 4/12/2016 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue, please contact Kaya Davis at kaya@exac.com or 1-800-392-2832. Please return the products to the following address:
Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653
Attention: Kaya Davis kaya@exac.com 352-337-3915 (Fax)
Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
제품 설명
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.