Medtronic StimLoc Burr Hole Cover Recall: Excess Nylon Flash Hazard

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Recalling firmMedtronic Neuromodulation7000 Central Ave Ne, N/A · Minneapolis, MN 55432-3568

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✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

What part numbers are affected by this recall?

Part numbers 3387S-40, 3389S-28, 3389S-40, 3391S-40, 3550S-01, and 924256 with specific lot numbers listed in the recall notice.

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.

How can I check if my product is affected?

Check the part number and lot number on your StimLoc Burr Hole Cover against the list provided in the recall notice.

Take action

Contact Medtronic

We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2228-2021 — Medtronic Medtronic

Hello,

I own a Medtronic that is covered by recall Z-2228-2021 from Medtronic.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Medtronic Neuromodulation recalls Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256

Lower-risk recall