Skip to content
Lower risk Medical device recall · FDA · Published December 4, 2024

Medtronic PIN surgical pins may not fit patient reference frame

Medtronic recalls two types of sterile surgical pins due to fitting issues with patient reference frames during image-guided surgery. Affected units have specific serial numbers and product codes.

🇺🇸 FDA recall #Z-1022-2025Medical deviceMedtronic ›
Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.200 Medtronic Dr · Lafayette, CO 80026-3735
✎ GovInfoNow plain-language explainer

Medtronic is recalling two types of sterile surgical pins that may not fit properly into patient reference frames during image-guided surgery. This could lead to incorrect positioning during procedures, potentially affecting surgical accuracy. Read more at govinfonow.com/recall/53332-medtronic-pin-surgical-pins-may-not-fit-patient-reference-frame.

Source Summary by GovInfoNow · govinfonow.com/recall/53332-medtronic-pin-surgical-pins-may-not-fit-patient-reference-frame · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1022-2025

Cite this page

“Medtronic PIN surgical pins may not fit patient reference frame.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53332-medtronic-pin-surgical-pins-may-not-fit-patient-reference-frame. Based on FDA recall #Z-1022-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1022-2025%22&limit=1).

The FDA announced on Dec. 4, 2024, that Medtronic Navigation, Inc. is recalling Sterile Percutaneous Reference Pin Sets due to complaints that the pins would not fit into the patient reference frame or adapter. The agency issued recall number Z-1022-2025 for the Class II device.

How to tell if you have it

  • Brand: Medtronic
  • Product: Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235
  • Product: Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236
  • Quantity: 67,370 pins
  • Distribution: Worldwide and U.S. Nationwide

The hazard

The recall is due to an increase in complaints that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter, according to the FDA.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since 2017-06-07. Other recent recalls of similar products include Medtronic StealthStation S8 App versions 1.3.0 and 1.3.2 (2024-08-22) and Medtronic Stealth S8 Software issues (2024-03-26). Similar recent recalls also include Think Surgical TMINI Tracking Arrays (2026-05-08), Medtronic Octopus 4 Tissue Stabilizer Model 29400 (2026-05-12), and XTANT Medical Xpress Pedicle Screw System (2026-02-18).

How to tell if you have this one

Check for product numbers 9733235 (100mm) or 9733236 (150mm) with specific serial/lot numbers listed in the recall notice. These pins are used in image-guided surgeries.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Numbers

    Verify if your pins have product numbers 9733235 or 9733236.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 4, 202412. FDA classified it Class II: Jan 27, 202523. Published in FDA’s Enforcement Report: Feb 5, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1022-2025 (December 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1022-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA