Medtronic StimLoc Burr Hole Cover — Class II medical device recall Z-2228-2021
Ongoing recall by Medtronic Neuromodulation, reported 2021-08-18, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. Excess nylon flash on the clip.
| Recall number | Z-2228-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2021-06-02 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, 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 |
| Quantity | 15,192 |
| Lot numbers | 082104420, 082202020A, 082202121A, 082203820A, 082207920A, 082211120A, 082214120A, 082224219A, 082228819A, 082232319A, 082234520A, 082235019A, 082300620, 082307020, 082307620, 082329819, 082332919, 082335119, 082335320, 82316820, 82326919, VA21X0Y, VA21YUS, VA21ZJU, VA21ZJV, VA21ZL1, VA21ZYP, VA222L5, VA227E2, VA227NQ, VA228PU, VA22C6L, VA22KF4, VA22LDZ, VA22MXM, VA22TDL, VA22V9R, VA22VZB, VA22Y79, VA236DC and 309 more |
| Model numbers | 3387S-40DBS, 3389S-28DBS, 3389S-40DBS, 3391S-40DBS, 3550S-01, 924256, DB-5000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2228-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.