In2Bones Recalls NEOVIEW Screws Due to Thread Dimensional Non-Conformity
In2Bones is recalling 26 units of NEOVIEW Screws Set due to dimensional non-conformity of the thread on the screw head.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a dimensional non-conformity but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
In2Bones, SAS is recalling 26 units of the NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R. The product is part of the NEOVIEW Plating System, which is intended for the fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius.
The recall is being conducted due to dimensional non-conformity of the thread on the screw head. The affected lot number is 1602134.
The product was distributed worldwide, specifically to Tennessee in the United States and internationally to France and Switzerland. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
- Manufacturer
- In2Bones, SAS
- Affected units
- 26
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)
- Lot number 1602134
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by In2Bones, SAS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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