Class 2 Device Recall Low Profile Screw, 4.5 x 20 mm

• Date Initiated by Firm: October 01, 2019
• Create Date: March 17, 2020
• Recall Status: Terminated on September 08, 2021
• Recall Number: Z-1510-2020
• Recall Event ID: 84030
• 510(K)Number: K141735
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
• Code Information: Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
• Recalling Firm/ Manufacturer: Arthrex, Inc.; 1370 Creekside Blvd; Naples FL 34108-1945
• For Additional Information Contact: William Potter; 800-933-7001
• Manufacturer Reason for Recall: Screws provided in the device package are 6 mm longer than intended.
• FDA Determined Cause: Employee error
• Action: Arthrex notified customers of the recall on about 10/01/2019, via "URGENT: REMOVAL NOTIFICATION" letter. Customers were informed that the Low Profile Screw, labeled as 4.5 x 20 mm, in their package measures 6 mm longer than intended. Customers were instructed to immediately discontinue use, sale, and distribution of affected screws and to acknowledge receipt of the recall notification. Direct customers were directed to contact Anthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. Arthrex agencies were directed to contact Arthrex Field Logistics Services at FLS@arthrex.com as soon as possible to arrange for return of affected products. An email also accompanied the recall letter and requested that customers return all affected product. Questions can be addressed to Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com.
• Quantity in Commerce: 20 units
• Distribution: US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
• 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 = HWC