Nextremity Solutions Recall 89764
Description: Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Nextremity Solutions Recall 89764 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0913-2022 |
| Event ID | 89764 |
| Event Description | Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument |
| Product Type | Devices |
| Distribution | Distribution US Nationwide, Japan, and the Netherlands |
| Quantity | 89 units |
| Recall Reason | Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery |
| Device Classification | 20220420 |
| Device Code Info | Lot Number: 168125017B UDI: 00817701020059 |
| Center Classification Date | 20220412 |
| Recall Initiation Date | 20220210 |
| Recalling Firm | Nextremity Solutions |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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