Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spine Referencing Instrumentation Recalled by Medtronic Navigation, Inc. Due to Potential for Spinal Clamps to be damaged when...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc. directly.
Affected Products
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.
Quantity: 2,051 units total
Why Was This Recalled?
Potential for Spinal Clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
Where Was This Sold?
This product was distributed to 43 states: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC
About Medtronic Navigation, Inc.
Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report