medical Class II Updated 2018-09-12

Encore Medical, Lp recalls Foundation Modular Femoral Stem, Part Number, 220-10-110. K

Recalled 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.

Hazard / Issue

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

Issued by

FDA

Affected States: AZ, MO, MS, NY, OK, UT
Lot/Code Info: All. Lots-866A1011, 866A1022
View official government recall

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