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Encore Medical, Lp recalls Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee i
Recalled September 12, 2018 · FDA recall Z-2967-2018 · Encore Medical
Hazard
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. · FDA Class II
Units
12
Sold at
U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
Description
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Product
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.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →