Class 2 Device Recall Knee replacement system

• Date Initiated by Firm: January 07, 2011
• Create Date: June 26, 2015
• Recall Status: Terminated on December 27, 2011
• Recall Number: Z-1740-2011
• Recall Event ID: 57705
• 510(K)Number: K060569
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
• Code Information: Lot Number: 670675.
• Recalling Firm/ Manufacturer: Ortho Development Corporation; 12187 South Business Park Dr; Draper UT 84020
• For Additional Information Contact: 801-619-3450
• Manufacturer Reason for Recall: Components of a replacement knee system could be mislabeled.
• FDA Determined Cause: Error in labeling
• Action: The firm, Ortho Development, sent a "Field Notification Memo" date January 7, 2011 to its customers. The memo described the product, problem and action to be taken. The customers were instructed to promptly return any remaining parts of the listed product; locate all the parts in their inventory; identify any of the listed parts that may have been used in surgery; verify the quantity they have on hand and the quantity used in surgery and reconcile them with the quantity sent; if discrepancy exists, notify customer service resolution; prepare items for return and contact customer service to obtain RMA number. Once reconciled, arrangements would be made for sending new inventory and the return of unused parts. If you have any questions regarding this issue, please notify Regulatory Affairs Manager at (801) 619-3450.
• Quantity in Commerce: 25 units
• Distribution: Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
• 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