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
Reported: August 18, 2021 Initiated: June 2, 2021 #Z-2228-2021
Product Description
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 15,192
- 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
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medtronic Neuromodulation. Units affected: 15,192.
Why was this product recalled? ▼
Excess nylon flash on the clip.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2228-2021.
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