Class 2 Device Recall The OPTETRAK Logic CC Total Knee System

• Date Initiated by Firm: May 08, 2018
• Create Date: September 20, 2018
• Recall Status: Open, Classified
• Recall Number: Z-3209-2018
• Recall Event ID: 80763
• 510(K)Number: K150890
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
• Code Information: Catalog #: 02-012-60-2216 Serial Number: 5370045
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Courtney Ware; 352-377-1140
• Manufacturer Reason for Recall: Potentially have non-conforming internal threads.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Exactech, contacted the consignee on May 3, 2018 by telephone to notify the consignee to quarantine the device pending recall notice distribution. Exactech distributed an "URGENT MEDICAL DEVICE RECALL" notice dated May 7, 2018 to the consignee in possession of affected inventory by electronic mail on May 7, 2018. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech at recalls@exac.com. On May 15, 2018, the recalled device was returned to Exactech and quarantined. If you have any questions, contact Sr. Manager, Regulator Affairs at 352-327-4613.
• Quantity in Commerce: 1
• Distribution: US Distribution to Ohio only.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JWH