Z-2869-2017Class II

Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm...

Name: Z-2869-2017 Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm...
Creator: In2Bones, SAS
Published: 2017-07-13
License: https://open.fda.gov/license/

In2Bones SAS / initiated 2017-07-13 / Terminated / root cause: design

FDA source

In2Bones, SAS began a recall of Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012... on 2017-07-13. FDA classified it as Class II and gives the reason as "The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2869-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Posted: 2017-08-03
Terminated: 2018-08-27
Recalling firm: In2Bones SAS
Product: Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy
Product code: HRS Plate, Fixation, Bone
Reason for recall: The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
Root cause tag: design
FDA root cause: Device Design
Action: In2Bones sent a Field Safety Corrective Action letter dated July 13, 2017, to all affected customers. The consignee was directed to remove the products from distribution and return it to the recalling firm. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +337 61 88 44 30 or by email: [email protected].
Quantity in commerce: 287 screws
Distribution: Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
Product codes and lots: All batch numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2869-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2869-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-03

Product code HRS

K160995Class IINEOVIEW Plating SystemIn2bones Sas / cleared 2016-06-10

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)