Class 2 Device Recall LOGIC Proximal Tibial Spacer Size 2.5

• Date Initiated by Firm: October 17, 2011
• Date Posted: August 21, 2012
• Recall Status: Terminated on November 07, 2013
• Recall Number: Z-2234-2012
• Recall Event ID: 62134
• 510(K)Number: K071738
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are 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. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
• Code Information: Catalog Number: 02-012-42-2508.
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Graham L. Cuthbert; 352-377-1140
• Manufacturer Reason for Recall: Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
• FDA Determined Cause: Device Design
• Action: The firm, Exactech, Inc., sent a "IMPORTANT PRODUCT RECALL NOTICE" date October 17, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately cease distribution or use of these products; extend this information to their accounts that may have possession of this product; verify if they have any of the subject Logic size 2.5 Proximal Tibial Spacer products, complete and return the attached PRODUCT RECALL FAX NOTICE form within five (5) working days via fax to: 352-337-3915, and to contact the firm inventory representative to confirm quantities at the location. For questions regarding inventory restocking, please call 1-800-392-2832.
• Quantity in Commerce: 70
• Distribution: Nationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA.
• 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