Class 2 Device Recall Exactech Opetrak Logic PS

• Date Initiated by Firm: November 21, 2023
• Date Posted: January 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0584-2024
• Recall Event ID: 93507
• 510(K)Number: K033883
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
• Code Information: GTIN 10885862001924, Serial Numbers: A649282, A649289
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: 352-377-1140
• Manufacturer Reason for Recall: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
• FDA Determined Cause: Packaging change control
• Action: Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
• Distribution: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
• 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