Z-0953-2017Class II

NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The...

Name: Z-0953-2017 NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The...
Creator: In2Bones, SAS
Published: 2016-12-19
License: https://open.fda.gov/license/

In2Bones SAS / initiated 2016-12-19 / Terminated / root cause: design

FDA source

In2Bones, SAS began a recall of 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... on 2016-12-19. FDA classified it as Class II and gives the reason as "Dimensional non-conformity of the thread on the screw head". 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-0953-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Posted: 2017-01-06
Terminated: 2017-02-01
Recalling firm: In2Bones SAS
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: Dimensional non-conformity of the thread on the screw head.
Root cause tag: design
FDA root cause: Component design/selection
Action: IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below: 1. Identify all the devices with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only: Identify all the devices with the batches subject of this recall that were delivered to your customers, and if relevant, instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to comply with the recommendations listed. This fax back form will enable In2Bones to conduct effectiveness checks. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at +33 4 72 29 26 26 / +33 7 61 88 44 30 or by email: [email protected]. For questions regarding this recall call 844-602-6637.
Quantity in commerce: 40 units
Distribution: Worldwide Distribution - US TN only and Internationally to France and Switzerland
Product codes and lots: Lot Numbers: 1604154, 1605083, 1606068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0953-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0952-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06
Z-0953-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06
Z-0954-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06

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)