CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Neoview(r) Screws Set recalled by In2Bones, SAS

In2Bones, SAS is recalling Neoview(r) Screws Set, distributed nationwide in the US. The recall was initiated on 19 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 1602134

Quantity recalled26 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0954-2017
FDA event ID: 76104
Recalling firm: In2Bones, SAS, Ecully
Classification: Class II
Status: Terminated
Recall initiated: 19 Dec 2016
FDA classified: 6 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Dec 2016	Recall initiated by company
6 Jan 2017	Classified by FDA	+18 days
18 Jan 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Dimensional non-conformity of the thread on the screw head.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US TN only and Internationally to France and Switzerland

Nationwide Tennessee

Questions about this recall

Is Neoview(r) Screws Set recalled?

Yes. In2Bones, SAS recalled Neoview(r) Screws Set on 19 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-0954-2017.

Why was it recalled?

Dimensional non-conformity of the thread on the screw head.

Which lots are affected?

Lot number 1602134

Where was it sold?

Worldwide Distribution - US TN only and Internationally to France and Switzerland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from In2Bones, SAS

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27 Mar 2024Device	CLASS II	I.B.S¿ 5-C Compression screw - diam lg recalled by In2Bones, SAS	In2Bones, SAS	Packaging Defects	Nationwide
31 Mar 2021Device	CLASS II	In2Bones Shannon Percutaneous Burr recalled by In2Bones, SAS	In2Bones, SAS	Device Malfunction	Nationwide
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