Class 2 Device Recall Arthrex

• Date Initiated by Firm: March 25, 2022
• Create Date: May 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1035-2022
• Recall Event ID: 89984
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: K-Wire, 1.35 mm x 170 mm
• Code Information: Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084
• Recalling Firm/ Manufacturer: Arthrex, Inc.; 1370 Creekside Blvd; Naples FL 34108-1945
• Manufacturer Reason for Recall: Products do not meet length and diameter specifications.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm sent a recall notification to the consignees on 03/25/2022 via email. The consignees were instructed to discontinue use, sale, and distribution of the product. The consignees were also instructed to contact FLS@arthrex.com to arrange return of the affected product.
• Quantity in Commerce: 300 pieces
• Distribution: Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.
• 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.