VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
This recall has been terminated (originally issued October 8, 2021).
- Recall Initiated
- October 8, 2021
- Terminated
- September 30, 2024
- Recall Number
- Z-0397-2022
- Quantity
- 18 boxes (5 units/box)
- Firm Location
- Kalona, IA
- Official Source
- View on FDA website ↗
Reason for Recall
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
Lot / Code Info
Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818
Root Cause
Device Design
Action Taken
The firm distributed an "URGENT: MEDICAL DEVICE RECALL" notice on 10/21/2021 by email. The notice explained the problem and requested acknowledgement of the notice. Entities further distributing the products were directed to notify those to whom the devices were distributed. The firm will be replacing the units.