FDA Device recall Z-0659-2020
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 by Medtronic Navigation, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0659-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-30 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
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.
Identifiers
| code_info | Lot Numbers: 0009754921 0009921274 0009940846 0009921273 0009921276 0009952564 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0659-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.