FDAFDA · Food and drugs·Recall number Z-3141-2017
Spine Referencing Instrumentation, Double 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.
Published September 27, 2017 · Recall initiated: June 29, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- 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.
- Lot
- P/N 9734723, 9734723K
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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