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U.S. Department of Health and Human Services

Class 2 Device Recall NEO(R) NonLocking screws

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  Class 2 Device Recall NEO(R) NonLocking screws see related information
Date Initiated by Firm July 13, 2017
Create Date August 03, 2017
Recall Status1 Terminated 3 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
Recalling Firm/
In2Bones, SAS
28 Chemin du petit Bois
Ecully France
For Additional Information Contact Tommy L. Turpin
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 2
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 and Original Applicant = In2Bones SAS