Z-1085-2024 Class II Ongoing
FDA device recall Z-1085-2024 was initiated by Stryker, Inc. on December 6, 2023 and is designated Class II. Reason for recall: The microcatheter IFU contains an intended use that has not been evaluated by the FDA. The recall status is ongoing. Affected quantity: 63 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- December 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 units
Product Description
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Reason for Recall
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
Distribution Pattern
US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Code Information
UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674