uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar he...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2427-2015.
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2427-2015.
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-2427-2015.
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: uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar he.... The notice was published on June 24, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 16,992 units are potentially affected.