# FDA recall Z-2869-2017

> **In2Bones, SAS** · Class II · device recall initiated 2017-07-13.

## 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

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-2869-2017
- **Recalling firm:** In2Bones, SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-13
- **Report date:** 2017-08-09
- **Termination date:** 2018-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ecully, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2869-2017

## Citation

> AI Analytics. FDA recall Z-2869-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2869-2017. Source: US FDA. Licensed CC0.

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