Class 2 Device Recall WRIGHT EVOLVE Proline Head

• Date Initiated by Firm: December 27, 2019
• Create Date: February 06, 2020
• Recall Status: Terminated on July 23, 2021
• Recall Number: Z-1101-2020
• Recall Event ID: 84673
• 510(K)Number: K060731
• Product Classification: Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
• Product: WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
• Code Information: Lot Code 1633010
• Recalling Firm/ Manufacturer: Wright Medical Technology, Inc.; 1023 Cherry Rd; Memphis TN 38117-5423
• Manufacturer Reason for Recall: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
• FDA Determined Cause: Process control
• Action: The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.
• Quantity in Commerce: 39 devices
• Distribution: US
• 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 = KWI