Z-0952-2017 Class II Terminated

Recalled by In2Bones, SAS — Ecully

Recall Details

Product Type
Devices
Report Date
January 18, 2017
Initiation Date
December 19, 2016
Termination Date
February 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

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.

Distribution Pattern

Worldwide Distribution - US TN only and Internationally to France and Switzerland

Code Information

Lot Numbers: a) 1602064, b) 1606067