The Recall Desk
HighFDA (Devices)·Z-2746-2017·Announced 2017-07-26

Medtronic Navigation Recalls Spine Tool Install CD Version 25

Medtronic Navigation is recalling 108 Spine Tool Install CD units (Model 9731958) due to a software issue that may prevent navigation of surgical instruments during spine procedures.

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. The hazard involves a software failure that prevents the navigation of surgical instruments during procedures, which is a risk-of-harm product issue where specific injuries are not yet reported in the source text.

Plain-English summary

Medtronic Navigation, Inc. is recalling 108 units of the Spine Tool Install CD, Version 25 (Model Number 9731958). The recall involves a software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 when configured with this specific install CD.

The identified issue may result in users being unable to navigate the Navigated Elevate Inserter with the StealthAiR Spine Frame during spine surgical procedures. The affected product was distributed nationwide in the United States and in Brazil, Germany, Switzerland, and Great Britain.

The affected install CD is included in several specific kits, including the Universal Navlock, Capstone Trials, Clydesdale Trials, TLIF/DLIF Inserter, and various Solera driver and tap kits. Users should contact Medtronic Navigation for further instructions on how to proceed with the recall.

The recalled product

Product
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Manufacturer
Medtronic Navigation, Inc.
Category
Medical Device — Surgical Navigation Software
Hazard
Affected units
108

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 (10)

  • INST SET 9734834 CAPSTONE TRIALS
  • INST SET 9734835 CLYDESDALE TRIALS
  • INST SET 9734836 TLIF/DLIF INSERTER
  • INST SET 9735283 SOLERA 5.5/6.0 DRIVERS
  • INST SET 9735284 SOLERA NONCAN TAPS
  • INST SET 9735285 SOLERA ILIAC TAPS
  • TAPS KIT 9735465 SOLERA AWL-TIP TAPS
  • REF SET 9735500 SPINE REFRENCING
  • UPGRD KIT 9735522 SPINE REVISION
  • INSTR SET 9735607 VERTEX SELECT

Distribution

Distributed nationwide across the United States.

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