FDA-Device2022-04-20Class II

Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument

Nextremity Solutions
Hazard

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

Sold states
Distribution US Nationwide, Japan, and the Netherlands
Affected count
4 units
Manufactured in
1195 Polk Dr, N/A, Warsaw, IN, United States
Products
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0910-2022

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