FDA recall Z-1651-2025

Tornier, Inc · Class II · device

Product

stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented

Reason for recall

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

Distribution

OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany

Key facts

Status: Ongoing
Initiation date: 2025-03-03
Report date: 2025-04-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2025