Class 2 Device Recall Optetrak Constrained Condylar Offset Screw

• Date Initiated by Firm: September 19, 2017
• Create Date: November 20, 2017
• Recall Status: Terminated on June 21, 2021
• Recall Number: Z-0157-2018
• Recall Event ID: 78111
• 510(K)Number: K023186
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Graham Cuthbert; 352-377-1140
• Manufacturer Reason for Recall: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
• FDA Determined Cause: Labeling design
• Action: The recalling firm issued a letter dated 9/19/2017 via email to their customers.
• Quantity in Commerce: 386 devices
• Distribution: Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.