FDA recall Z-1826-2020

Product

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

Reason for recall

A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

Distribution

US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.

Key facts

Status

Terminated

Initiation date

2020-03-30

Report date

2020-05-06

Termination date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1826-2020