In2Bones Recalls Non-Locking Orthopedic Screws Due to Perioperative Breakage
In2Bones, SAS is recalling specific non-locking orthopedic screws after customer complaints reported breakage during insertion into the radius bone.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source reports device breakage during surgery (perioperative breakage) without explicit reports of patient injury or hospitalization, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
In2Bones, SAS is recalling specific non-locking screws used in the NEOVIEW Plating System. The affected products include NEO and DRP 0.27 screws in lengths of 10 mm, 12 mm, 14 mm, 16 mm, and 18 mm. The recall involves 287 screws distributed worldwide, including the United States (specifically Tennessee) and several European countries such as Italy, Portugal, Spain, Switzerland, the UK, and France.
The recall was initiated after the firm received several customer complaints reporting perioperative breakages of the NE0411 Non-Locking screws. These breakages occurred when the screws were being inserted into the radius diaphysis. The NEOVIEW Plating System is intended for the fixation of intra-articular and extra-articular fractures of the distal radius and for the reconstruction of the distal radius.
Healthcare providers and patients who have used or may have used these specific non-locking screws should contact In2Bones, SAS for further instructions on how to proceed. The recall covers all batch numbers for the listed screw lengths.
The recalled product
- 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 ST01
- Manufacturer
- In2Bones, SAS
- Affected units
- 287
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All batch numbers
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · In2Bones, SAS
See all →- HighMedical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
FDA (Devices) · 2024-03-27
- HighI.B.S. 6.5-C Compression Screw Batch Recalled for Dimensional Mix-Up
FDA (Devices) · 2024-03-27
- HighIn2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
FDA (Devices) · 2021-03-31
- ModerateIn2Bones Recalls 19 Locking Screws Due to Thread Dimensional Non-Conformity
FDA (Devices) · 2017-01-18
- ModerateIn2Bones Recalls NEOVIEW Screws Due to Thread Dimensional Non-Conformity
FDA (Devices) · 2017-01-18
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01