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Open, Classified

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

FDA Recall Z-2228-2021 · Posted None

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeGXR
Date Initiated2021-06-02
Product Quantity15,192

Reason for Recall

Excess nylon flash on the clip.

Firm Action

On June 2,2021 the firm sent letter with the following information: Dear Healthcare Professional, Medtronic is voluntarily recalling specific lots of the StimLoc" Burr Hole Cover due to a manufacturing issue resulting in excess nylon flash on the clip. Please review the information contained in this letter, quarantine any affected product (see Attachment A for list of affected lot numbers) in your inventory for return to Medtronic, and sign and return the customer confirmation form included with this letter. Medtronic email at [email protected] or Medtronic Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001096BURR HOLE COVER, MODEL XXImage-Guided Neurologics, Inc. · 2000-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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