Device product

Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument

Z-0913-2022

February 10, 2022

Class II

Product summary

Firm: Nextremity Solutions
Event: Event 89764
Status: Terminated
Classification: Class II
Quantity: 89 units
Official record key: device-enforcement:Z-0913-2022

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: 168125017B UDI: 00817701020059

Distribution pattern: Distribution US Nationwide, Japan, and the Netherlands

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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