The Recall Desk
HighFDA (Devices)·Z-0953-2017·Announced 2017-01-18

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

In2Bones is recalling 40 units of NEOVIEW locking screws due to dimensional non-conformity of the thread on the screw head. The recall covers units distributed in the US, France, and Switzerland.

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 involves a structural defect in a medical device used for fracture fixation. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

In2Bones, SAS is recalling 40 units of the NEO SCREW 02.7-14MM LOCKING (Ref W27 ST114) used in the NEOVIEW Plating System. The recall is due to a dimensional non-conformity of the thread on the screw head. The NEOVIEW Plating System is intended for the fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius.

The affected lot numbers are 1604154, 1605083, and 1606068. The products were distributed worldwide, specifically to the US (Tennessee only) and internationally to France and Switzerland. The recall is classified as Class II by the FDA.

Healthcare providers and facilities that have received these products should stop using them and contact In2Bones, SAS for further instructions. Consumers who have had these devices implanted should contact their healthcare provider for guidance.

The recalled product

Product
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, 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
40

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 (3)

  • Lot Numbers: 1604154
  • 1605083
  • 1606068

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

See all →

Same hazard · dimensional non conformity

See all →