Class 2 Device Recall VALOR(R) Nail, Right, Medium

• Date Initiated by Firm: March 14, 2018
• Create Date: April 13, 2018
• Recall Status: Terminated on October 05, 2020
• Recall Number: Z-1375-2018
• Recall Event ID: 79581
• 510(K)Number: K090857
• Product Classification: Rod, fixation, intramedullary and accessories - Product Code HSB
• Product: WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
• Code Information: Lot 1608296
• Recalling Firm/ Manufacturer: Wright Medical Technology, Inc.; 11576 Memphis Arlington Rd; Arlington TN 38002-9497
• For Additional Information Contact: 901-867-9971
• Manufacturer Reason for Recall: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
• FDA Determined Cause: Under Investigation by firm
• Action: Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product.
• Quantity in Commerce: 47 units
• Distribution: US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
• 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 = HSB