NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fix...
FDA Recall #Z-0954-2017 — Class II — December 19, 2016
Product Description
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
Reason for Recall
Dimensional non-conformity of the thread on the screw head.
Recalling Firm
In2Bones, SAS — Ecully
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26 units
Distribution
Worldwide Distribution - US TN only and Internationally to France and Switzerland
Code Information
Lot number 1602134
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated