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Lower risk Medical device recall · FDA · Published March 3, 2025

Tornier Latitude EV Humeral Revision Stem Trial Recall: Incorrect Part Marking

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.

🇺🇸 FDA recall #Z-1651-2025Medical deviceTornier ›
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Recalling firmTornier, Inc10801 Nesbitt Ave S · Bloomington, MN 55437-3109
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/52715-tornier-latitude-ev-humeral-revision-stem-trial-recall-incorrect-part.

Source Summary by GovInfoNow · govinfonow.com/recall/52715-tornier-latitude-ev-humeral-revision-stem-trial-recall-incorrect-part · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1651-2025

Cite this page

“Tornier Latitude EV Humeral Revision Stem Trial Recall: Incorrect Part Marking.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52715-tornier-latitude-ev-humeral-revision-stem-trial-recall-incorrect-part. Based on FDA recall #Z-1651-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1651-2025%22&limit=1).

The FDA announced on March 3, 2025, that Tornier, Inc. is recalling one lot of stryker Latitude EV Humeral Revision Stem Trials due to incorrect direct part marking. The agency issued recall number Z-1651-2025 for the Class II device distributed internationally.

How to tell if you have it

  • stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103
  • UPC 00846832015054
  • Batch Number CC0421265

The hazard

According to the FDA, a specific lot of Latitude Humeral Trial Stems has incorrect direct part marking. The laser marking indicates REF 9030103 (Large/Right/Yellow), but the device is actually REF 9030092 (Medium/Left/Red).

Context

GovInfoNow's records show Tornier, Inc. has 12 other recalls on record since February 8, 2018. Other recent recalls of similar products include Encore Medical RSP Humeral Socket Insert Recall (January 15, 2026), restor3d Veritas Standard Glenoid Baseplate Recall (June 30, 2026), and W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (May 22, 2026).

How to tell if you have this one

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.

  • Brand
    Tornier
  • Product
    stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Verify Device Marking

    Compare the laser marking on the device to the correct model (9030092) to ensure it matches the intended size and side.

How this recall unfolded

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Mar 3, 202512. FDA classified it Class II: Apr 22, 202523. Published in FDA’s Enforcement Report: Apr 30, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have the recalled device?

Contact Tornier directly to verify the device and determine if it needs replacement or adjustment.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1651-2025 (March 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1651-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA