FDA Medical devices recall · February 5, 2025

Medtronic PIN, 100mm STERILE PERCUTANEOUS recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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 202

Distribution

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.

States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1022-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.