FDA Enforcement
Class II
Ongoing
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Recall: Z-1085-2024
·
Reported February 21, 2024
Enforcement
- Recall Number
- Z-1085-2024
- Event ID
- 93678
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 21, 2024
- Initiation Date
- December 6, 2023
- Classification Date
- February 14, 2024
- Address
- 4870 West 2100 South, N/A, Salt Lake City, UT, 84104, United States
Description
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Reason
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Code Info
UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674
Distribution
US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Quantity
63 units