Recall Z-0953-2017— In2Bones, SAS
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: NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, 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: 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 recordK-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
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.