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Blue Belt Technologies MN recalls Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Recalled July 9, 2014 · FDA recall Z-1943-2014 · Blue Belt Technologies MN
Hazard
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral. · FDA Class II
Units
2
Sold at
US Nationwide Distribution in the states of CA, PA, and TX
Description
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
Product
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Manufacturer(s)
Blue Belt Technologies MN
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →