FDA-Device2018-09-12Class II
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Encore Medical, Lp
Hazard
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Sold states
U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
Affected count
12
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2967-2018Don't want to check this manually?
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