Medtronic StimLoc Burr Hole Cover Recall: Excess Nylon Flash Hazard
Recall of Medtronic StimLoc Burr Hole Covers with specific part numbers and lots due to excess nylon flash. Consumers should check their product details to determine if affected.
Lower-risk recall
Excess nylon flash on the clip.
Contact the company
What happened, in plain English
Medtronic is recalling certain StimLoc Burr Hole Covers that have excess nylon flash. This could cause the cover to become loose or misaligned during surgery, potentially leading to complications. Read more at govinfonow.com/recall/62435-medtronic-stimloc-burr-hole-cover-recall-excess-nylon-flash-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/62435-medtronic-stimloc-burr-hole-cover-recall-excess-nylon-flash-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2228-2021
Cite this page
“Medtronic StimLoc Burr Hole Cover Recall: Excess Nylon Flash Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62435-medtronic-stimloc-burr-hole-cover-recall-excess-nylon-flash-hazard. Based on FDA recall #Z-2228-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2228-2021%22&limit=1).
Why it’s dangerous
Excess nylon flash on the clip can cause the cover to become loose or misaligned during surgical procedures. This may lead to improper placement or complications during the surgery.
Who’s affected
Patients who have received the recalled StimLoc Burr Hole Covers as part of their spinal surgery. Surgeons and medical staff using these specific part numbers are most at risk.
How to tell if you have this one
Check the part number on your StimLoc Burr Hole Cover. Affected models include 3387S-40, 3389S-28, 3389S-40, 3391S-40, 3550S-01, and 924256 with specific lot numbers listed in the recall notice.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Details
Identify your StimLoc Burr Hole Cover's part number and lot number to determine if it's affected by this recall.
Where it went and when
Where it was distributed
Distributed in 46 states and D.C..
FDA distribution: “AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Hawaii” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, 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, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the product immediately?
No, the recall does not require immediate discontinuation. The hazard is low risk and only affects specific part numbers and lot numbers.
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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-2228-2021 (June 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2228-2021 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.