Z-3142-2017 Class II Terminated
FDA device recall Z-3142-2017 was initiated by Medtronic Navigation, Inc. on June 29, 2017 and is designated Class II. 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 followi… The recall status is terminated (terminated July 24, 2023). Affected quantity: 2,051 units total.
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
- 2,051 units total
Product Description
Reason for Recall
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.