# FDA recall Z-2228-2021

> **Medtronic Neuromodulation** · Class II · device recall initiated 2021-06-02.

## Product

Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

## Reason for recall

Excess nylon flash on the clip.

## 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

## Key facts

- **Recall number:** Z-2228-2021
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-02
- **Report date:** 2021-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2228-2021

## Citation

> AI Analytics. FDA recall Z-2228-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2228-2021. Source: US FDA. Licensed CC0.

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