Recall Z-2228-2021 ยท GXR Cover, Burr Hole
Medtronic Neuromodulation
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
| Date | Jun 2, 2021 |
| Status | Open, Classified |
| Reason | Excess nylon flash on the clip. |
| Root cause | Process control |
| 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 RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001096 | BURR HOLE COVER, MODEL XX Image-Guided Neurologics, Inc., Oct 25, 2000 |