Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2810-2015.
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2810-2015.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Stryker Howmedica Osteonics Corp. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2810-2015.
Stryker Howmedica Osteonics Corp.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Stryker Howmedica Osteonics Corp. Recall FAQ
Stryker Howmedica Osteonics Corp. is the subject of a medical implants safety report: Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component. The notice was published on June 25, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 16 units are potentially affected.