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

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)

Details from the source

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 Quantity: 5 units Lot/code info: GTIN 00846832015054, Batch Number CC0421265

UPC codes

00846832015054

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.