Home / Recalls / Medtronic Navigation, Inc. / Z-1022-2025

Z-1022-2025 Class II Ongoing

Recalled by Medtronic Navigation, Inc. — Lafayette, CO

Recall Details

Product Type
Devices
Report Date
February 5, 2025
Initiation Date
December 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67,370 pins

Product Description

Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.

Reason for Recall

Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Czech Republic, Denmark, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Arab Emirates, United Kingdom, Vietnam.

Code Information

Sterile Percutaneous Pin, 100mm Product Number: 9733235 UDI-DI code: 00613994247872 Serial/Lot Numbers: 2023071142 2023080327 2023080330 2023091351 2023091353 2023091354 2023091355 2023091356 2023100459 2023100460 2023101139 2023101140 2023101470 2023101472 2023101473 2023110368 2023110370 2023110371 2023110821 2023110823 2023110824 2023111489 2023111490 2023111491 2023120008 2023120009 2023120434 2023120834 2023120835 2023121177 2024010330 2024010332 2024011153 2024021011 2024021014 2024021015 2024021016 2024021100 2024021103 2024021365 2024040327 2024040895 2024040896 2024050686 2024050687 2024050688 2024051221 2024051222 2024051225 2024051226 2024060262 2024060479 2024060480 2024060484 2024070408 2024070409 2024070410 2024070411 2024070414 2024070415 2024080529 2024080530 GTIN code (Japan only): 00643169105676 Serial/Lot Numbers: 2023091351 2023100459 2023101140 2023101472 2023101473 Sterile Percutaneous Pin, 150mm Product Number: 9733236 UDI-DI code: 613994247865 Serial/Lot Numbers: 2023071143 2023071144 2023091357 2023091358 2023091359 2023091360 2023101141 2023101142 2023101471 2023110372 2023110373 2023110822 2023111492 2023120010 2023120039 2023120040 2023120041 2023120042 2023120431 2023120432 2023120433 2023120831 2023120832 2023121178 2024010333 2024010334 2024011154 2024011155 2024021012 2024021013 2024021101 2024021102 2024021364 2024021366 2024021367 2024040325 2024040328 2024040897 2024040898 2024050689 2024051224 2024060263 2024060481 2024060482 2024060483 2024070413 2024070416 2024070417 2024080534 2024080535 GTIN code (Japan only): 643169105669 Serial/Lot Numbers: 2023071143 2023071144 2023101142 2023110822 2023120010

Other recalls by Medtronic Navigation, Inc.

  • Z-0050-2025 Class II — StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stealth (August 22, 2024)
  • Z-1776-2024 Class I — Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used i (March 26, 2024)
  • Z-0698-2024 Class II — Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS (November 28, 2023)
  • Z-0699-2024 Class II — Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS (November 28, 2023)
  • Z-0188-2024 Class I — StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The Stealt (September 27, 2023)
  • Z-1666-2023 Class I — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 (April 11, 2023)
  • Z-1630-2023 Class I — StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), (April 11, 2023)
  • Z-1039-2023 Class II — AxiEM" Non-Invasive Patient Tracker (December 15, 2022)
  • Z-0953-2023 Class II — RadiaLux Lighted Retractor (Pink), REF: 50-101-1 (December 8, 2022)
  • Z-0244-2023 Class II — Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM T (October 14, 2022)