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
FDA Recall Z-2869-2017 · Posted None
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Recalling FirmIn2Bones, SAS
Recall StatusTerminated
Product CodeHRS
Date Initiated2017-07-13
Date Terminated2018-08-27
Product Quantity287 screws
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
Firm 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: [email protected].
Root Cause
Device Design
Distribution Pattern
Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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