Device product
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
Z-0911-2022
Product summary
- Event
- Event 89764
- Status
- Terminated
- Classification
- Class II
- Quantity
- 459 units
- Official record key
device-enforcement:Z-0911-2022
Official wording
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
Code information: Lot Number: 168117318C, 168125017D UDI: 00817701020004
Distribution pattern: Distribution US Nationwide, Japan, and the Netherlands
Derived failure modes
-
Unknown
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