FDA recall Z-1458-2020

Product

Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Reason for recall

Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant

Distribution

International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.

Key facts

Status

Terminated

Initiation date

2020-02-12

Report date

2020-03-18

Termination date

2020-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2020