In2bones Sas
Immeuble Sequoia 3, Saint-Priest Rhone, FR
Registered product codes
32 product codes
Recent MDR events
90 on file
- IBS¿Jun 17, 2026Malfunction3010470577-2026-05071
- IBS¿Jun 10, 2026Malfunction3010470577-2026-06031
- IBS¿Apr 28, 2026Malfunction3010470577-2026-04041
- IN2BONESMar 30, 2026Malfunction3010470577-2020-09151
- TRIWAYMar 30, 2026Malfunction3010470577-2026-03011
- IBS¿Mar 30, 2026Malfunction3010470577-2020-10051
- NEOSYSMar 26, 2026Malfunction3010470577-2020-06021
- G01 01511Mar 26, 2026Malfunction3010470577-2020-06091
- KIRSCHNER WIREMar 25, 2026Malfunction3010470577-2020-02261
- NEOFUSEMar 25, 2026Malfunction3010470577-2020-02341
Recalls
10 on file
- Open, ClassifiedMar 20, 2024
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
View FDA record ↗ - Open, ClassifiedMar 20, 2024
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
View FDA record ↗ - TerminatedJan 6, 2017
Dimensional non-conformity of the thread on the screw head.
View FDA record ↗ - TerminatedJan 6, 2017
Dimensional non-conformity of the thread on the screw head.
View FDA record ↗ - TerminatedJan 6, 2017
Dimensional non-conformity of the thread on the screw head.
View FDA record ↗ - TerminatedDec 9, 2015
One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.
View FDA record ↗ - TerminatedMar 25, 2015
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
View FDA record ↗ - TerminatedMar 25, 2015
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
View FDA record ↗ - TerminatedUnknown
This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
View FDA record ↗ - TerminatedUnknown
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
View FDA record ↗
Compliance history
Matched by FEI 3010470577.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 4, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Sep 4, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17(a)(2)Sep 4, 2025
Lack of System for Determining MDR Events
- 21 CFR 820.30(b)Sep 4, 2025
Design plans - Lack of or inadequate
- 21 CFR 820.90(a)Sep 4, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Sep 4, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(e)Sep 4, 2025
Records of complaint investigation - UDI
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.