Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Medtronic Navigation, Inc. · Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and…
- Status
- Ongoing
- City
- Lafayette
- State
- CO
- Country
- United States
- Classification
- Class II
- Product type
- Devices
- Event ID
- 99895
- Recalling firm
- Medtronic Navigation, Inc.
- Address 1
- 200 Medtronic Dr
- Postal code
- 80026-3735
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Recall number
- Z-0195-2027
- Product description
- Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
- Product quantity
- 83,594 units
- Recall initiation date
- 20260831
- Center classification date
- 20261016
- Report date
- 20261028
- Distribution pattern
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: Canary Islands, Iceland, Northern Ireland, Martinique, China , Taiwan, Hong Kong,
- Reason for recall
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
- Code info
UDI: 20805832070023/ Lot codes: 2503141 2503241 2503411 2503491 2504081 2504091 2504211 2504301 2504331 2505211 2505221 2505351 2505641 2505651 2505681 2506081 2506161 2506341 2506551 2506581 2509781 2509791 2509811 2510121 2510741 2510751 2511101 2511121 2511501 2511601