Recall Z-0954-2017— In2Bones, SAS

Name: FDA recall Z-0954-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Class II · Terminated

Class II FDA medical device recall by In2Bones, SAS, initiated 2016-12-19, terminated 2017-02-01. It names one FDA 510(k) clearance: K160995. Product: 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: Dimensional non-conformity of the thread on the screw head..

Recalling firm: In2Bones, SAS
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Terminated: 2017-02-01
Firm location: Ecully, France

510(k) clearances named in this recall

1 on FDA's record

K160995 — NEOVIEW Plating SystemIn2bones Sas·cleared 2016-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.