The Recall Desk
ModerateFDA (Devices)·Z-0952-2017·Announced 2017-01-18

In2Bones Recalls 19 Locking Screws Due to Thread Dimensional Non-Conformity

In2Bones is recalling 19 locking screws from the NEOVIEW Plating System 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 injuries, illnesses, or specific functional failures, fitting the criteria for a moderate severity recall involving a potential defect without reported harm.

Plain-English summary

In2Bones, SAS is recalling 19 units of the SCREW 02.7-12MM LOCKING (Ref W27 ST112) from the NEOVIEW Plating System. The product is intended for the fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius.

The recall was initiated due to a dimensional non-conformity of the thread on the screw head. The affected units are identified by Lot Numbers 1602064 and 1606067.

The recalled products were distributed in the United States (Tennessee only) and internationally to France and Switzerland. No specific instructions for consumers or healthcare providers are provided in the source text.

The recalled product

Product
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France 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
19

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 (2)

  • Lot Numbers: a) 1602064
  • b) 1606067

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 →

Related recalls

Same manufacturer · In2Bones, SAS

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Same hazard · dimensional non conformity

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