Tornier recalls specific Latitude EV Humeral Revision Stem Trial models with incorrect part markings that could lead to improper fitting. Affected units have a laser marking of 9030103 but are actually 9030092. Consumers should contact Tornier for verification.
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)
Tornier is recalling a specific model of humeral revision stem trial prosthesis due to incorrect part markings. This could lead to improper fitting if used without verification, potentially causing complications during surgery.
The recalled model has a laser marking that indicates it is a large right side 150mm stem, but it is actually a medium left side stem. This mismatch could lead to improper surgical fitting if used without verification.
Patients who received the specific model (9030103) for the right side, large size, 150mm humeral revision stem trial. Surgeons and medical staff using this model during procedures are at risk of improper fitting.
Check for the laser marking '9030103' on the device. The affected model is for the right side, large size, 150mm humeral revision stem trial. This model was sold with batch number CC0421265.
Compare the laser marking on the device to the correct model (9030092) to ensure it matches the intended size and side.
The recalled model has a laser marking of 9030103, but it is actually a 9030092 model intended for the left side, medium size.
Check for the laser marking '9030103' on the device. Affected units are for the right side, large size, 150mm humeral revision stem trial with batch number CC0421265.
Contact Tornier directly to verify the device and determine if it needs replacement or adjustment.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1651-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1651-2025 from Tornier. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
