Stryker, Inc. Recall 93678
Description: Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Stryker, Inc. Recall 93678 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1085-2024 |
| Event ID | 93678 |
| Event Description | Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA. |
| Quantity | 63 units |
| Recall Reason | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
| Device Classification | 20240221 |
| Device Code Info | UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674 |
| Center Classification Date | 20240214 |
| Recall Initiation Date | 20231206 |
| Recalling Firm | Stryker, Inc. |
| Initial Notification | Letter |
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