Z-2408-2019 Class II Terminated
FDA device recall Z-2408-2019 was initiated by Ad-Tech Medical Instrument Corporation on June 18, 2019 and is designated Class II. Reason for recall: Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved… The recall status is terminated (terminated January 20, 2023). Affected quantity: 22,810 devices with possible affected supplemetal information.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2019
- Initiation Date
- June 18, 2019
- Termination Date
- January 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,810 devices with possible affected supplemetal information
Product Description
Reason for Recall
Distribution Pattern
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide distribution to Albania, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam.