FDA-Device2025-04-30Class II
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Tornier, Inc
Hazard
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)
Sold states
OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Affected count
5 units
Manufactured in
10801 Nesbitt Ave S, N/A, Bloomington, MN, United States
Products
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2025Don't want to check this manually?
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