Non-Locking screws in the following lengths: — Class II medical device recall Z-2869-2017
Terminated recall by In2Bones, SAS, reported 2017-08-09, distributed in TN. The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking scr
| Recall number | Z-2869-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | In2Bones, SAS, Ecully, N/A, France |
| Recall initiated | 2017-07-13 |
| Classified | 2017-08-03 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2018-08-27 |
| Distributed | TN |
| Countries outside the US | CH, ES, FR, GB, IT, PT |
| Quantity | 287 screws |
| Model numbers | ST010, ST012, ST014, ST016, ST018, W27 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2869-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.