medical Class II Updated 2025-04-30

Tornier, Inc recalls stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, S

Recalled Product

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

Hazard / Issue

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)

Issued by

FDA

Distribution: OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Lot/Code Info: GTIN 00846832015054, Batch Number CC0421265
View official government recall

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