The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0954-2017·Announced 2017-01-18

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Medical Device — Orthopedic Implant
Hazard
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.

See all 3 products in this recall →

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