Nextremity Solutions recalls Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

Recall date

February 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0911-2022

FDA classification

Class II

Brand / firm

Nextremity Solutions

Sold / distributed

Distribution US Nationwide, Japan, and the Netherlands

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument