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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77781

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
In2Bones, SAS

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2869-2017
Recall number
Z-2869-2017
Initiated
July 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
In2Bones, SAS
Quantity
287 screws

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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

Code information

All batch numbers

Distribution pattern

Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France