Class 2 Device Recall NEO(R) NonLocking screws

• Date Initiated by Firm: July 13, 2017
• Create Date: August 03, 2017
• Recall Status: Terminated on August 27, 2018
• Recall Number: Z-2869-2017
• Recall Event ID: 77781
• 510(K)Number: K160995
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy
• Code Information: All batch numbers
• FEI Number: 3010470577
• Recalling Firm/ Manufacturer: In2Bones, SAS; 28 Chemin du petit Bois; Ecully France
• For Additional Information Contact: Tommy L. Turpin; 901-260-7931
• Manufacturer Reason for Recall: The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
• FDA Determined Cause: Device Design
• Action: In2Bones sent a Field Safety Corrective Action letter dated July 13, 2017, to all affected customers. The consignee was directed to remove the products from distribution and return it to the recalling firm. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +337 61 88 44 30 or by email: qualite@in2bones.com.
• Quantity in Commerce: 287 screws
• Distribution: Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
• 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 = HRS