Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1623-2016.
Incorrect component used to manufacture distal femoral replacement.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1623-2016.
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 Stanmore Implants Worldwide Ltd. 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-1623-2016.
Stanmore Implants Worldwide Ltd.
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.
Stanmore Implants Worldwide Ltd. Recall FAQ
Stanmore Implants Worldwide Ltd. is the subject of a medical implants safety report: Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960. The notice was published on April 12, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.