Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee sy...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2967-2018.
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2967-2018.
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 Encore Medical, Lp 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-2967-2018.
Encore Medical, Lp
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.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
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.
Encore Medical, Lp Recall FAQ
Encore Medical, Lp is the subject of a medical implants safety report: Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee sy.... The notice was published on May 14, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 12 units are potentially affected.