Home / Recalls / Ad-Tech Medical Instrument Corporation / Z-2408-2019

Z-2408-2019 Class II Terminated

Recalled by Ad-Tech Medical Instrument Corporation — Oak Creek, WI

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

Skull Anchor Bolts

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 for such use.

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.

Code Information

All catalog numbers and lot numbers distributed through May 30, 2019

Other recalls by Ad-Tech Medical Instrument Corporation

  • Z-0219-2025 Class II — AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A s (September 19, 2024)
  • Z-0221-2025 Class II — AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A s (September 19, 2024)
  • Z-0220-2025 Class II — AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A s (September 19, 2024)
  • Z-2494-2021 Class II — Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of co (August 9, 2021)
  • Z-2496-2021 Class II — Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting (August 9, 2021)
  • Z-2495-2021 Class II — Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose (August 9, 2021)
  • Z-2544-2019 Class II — AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2 (August 27, 2019)
  • Z-2406-2019 Class II — Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electro (June 18, 2019)
  • Z-2204-2019 Class II — LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anc (June 18, 2019)
  • Z-2407-2019 Class II — Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, (June 18, 2019)