Medtronic Navigation, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3139-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 29, 2017

Date Posted: September 27, 2017

Recall Number: Z-3139-2017

Event ID: 77894

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,051 units total

Code Information:

P/N 9734715, 9734715K

Distribution Pattern:

Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania, Australia, Bangladesh, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Kenya, Latvia, Luxembourg, Malaysia, Martinique, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, & Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated