Z-3141-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2017
- Initiation Date
- June 29, 2017
- Termination Date
- July 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2051 units
Product Description
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.
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.
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.
Code Information
P/N 9734723, 9734723K