FDA recall Z-0913-2022

Product

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

Reason for recall

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

Distribution

Distribution US Nationwide, Japan, and the Netherlands

Key facts

Status

Terminated

Initiation date

2022-02-10

Report date

2022-04-20

Termination date

2024-10-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0913-2022