The Recall Desk
HighFDA (Devices)·Z-0441-2013·Announced 2012-12-05

Medtronic Recalls Vertex Max Drill Tubes Due to Threading Defect

Medtronic is recalling 12 Vertex Max Drill Tubes due to a defect in the internal threading used for component setup.

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 involves a medical device defect that could impact surgical precision, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Medtronic Navigation, Inc. is recalling 12 units of the Vertex Max Drill Tube, a component of the Navigated Vertex Max Drill Guide Set (item 9733370). The device is intended to be used with a Medtronic Computer Assisted Surgery System to assist with screw placement during spine surgical procedures. The specific lot number is 120203.

The recall is being conducted due to a defect related to the internal threading for component setup. The device is reusable and requires sterilization according to product labeling.

The affected units were distributed worldwide, including nationwide in the United States (specifically CA, FL, MA, LA, and MI) and in Switzerland, Saudi Arabia, Lebanon, Canada, and Korea. Users should stop using the affected drill tubes and contact Medtronic for further instructions.

The recalled product

Product
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical pr
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
12

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 120203.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same manufacturer · Medtronic Navigation, Inc.

See all →