The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0574-2014·Announced 2014-01-01

SpineFrontier Recalls Mismarked and Unmarked Indus Invue Cervical Screws

SpineFrontier, Inc. is recalling 922 Indus Invue Screws because they are mismarked or unmarked. These screws are used to secure anterior cervical plates.

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, but the source text identifies the issue as mismarked and unmarked screws without reporting any injuries, illnesses, or structural failures. This aligns with the rubric for minor labeling errors or low-risk contamination where no harm has been reported.

Plain-English summary

SpineFrontier, Inc. is recalling 922 units of Indus Invue Screws (model lM71059-XX, 04.2mm SelfDrilling). These medical devices are used to secure the Invue Anterior Cervical Plate in position. The recall is due to the screws being mismarked and unmarked.

The affected products were distributed nationwide, including the District of Columbia and the states of Ohio, Texas, Kansas, Massachusetts, Indiana, Colorado, New York, Alabama, and Michigan. The specific lot and serial numbers involved are IM71 059-01 (Lot 0000 lM71059-02) and IM71059-02 (Lot 035M).

Healthcare providers and patients should check their inventory and medical records for these specific lot numbers. If you have these screws, contact SpineFrontier, Inc. for instructions on how to return or replace the product.

The recalled product

Product
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Manufacturer
SpineFrontier, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
922

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/Serial Number: IM71 059-01: Lot 0000 lM71059-02
  • IM71059-02: Lot 035M

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 4 recalled by SpineFrontier, Inc. 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 4 products in this recall →

Related recalls

Same manufacturer · SpineFrontier, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls