Recall Z-0657-2020 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
| Date | Oct 30, 2019 |
| Status | Open, Classified |
| Reason | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery. |
| Root cause | Process control |
| Action | On 10/24/2019, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to consignees via FedEx. The customer notification letter as consignees to do the following: 1. Identify, segregate, and quarantine affected products within your inventory 2. Complete the Customer Confirmation Form. Return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. 3. Contact Medtronic at 1-888-826-5603 to receive a return materials authorization (RMA) and schedule replacement product. Return affected products to: 4. Medtronic Product Service |
| Quantity | 10,448 disposable biopsy needles |
| Distribution | US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jerse |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971247 | SNT DISPOSABLE BIOPSY NEEDLE Surgical Navigation Technologies, Inc., Jun 16, 1997 |