PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 18, 2017 Initiated: December 19, 2016 #Z-0952-2017

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.

Details

Recalling Firm
In2Bones, SAS
Units Affected
19 units
Distribution
Worldwide Distribution - US TN only and Internationally to France and Switzerland
Location
Ecully

Frequently Asked Questions

What product was recalled?
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. Recalled by In2Bones, SAS. Units affected: 19 units.
Why was this product recalled?
Dimensional non-conformity of the thread on the screw head.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0952-2017.