SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130...
FDA Recall #Z-0952-2017 — Class II — December 19, 2016
Product Description
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France 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
19 units
Distribution
Worldwide Distribution - US TN only and Internationally to France and Switzerland
Code Information
Lot Numbers: a) 1602064, b) 1606067
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated