FDA recall Z-1921-2023

Howmedica Osteonics Corp. · Class II · device

Product

Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

Reason for recall

The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.

Distribution

International distribution in the country of Ireland.

Key facts

Status
Ongoing
Initiation date
2023-05-03
Report date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1921-2023