FDA recall Z-1284-2023

Product

G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

Reason for recall

The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

Distribution

US Distribution to states of: AZ, FL, GA, MI, NE, and TX.

Key facts

Status

Ongoing

Initiation date

2023-02-06

Report date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2023