FDA-Device2014-07-09Class II
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
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.
Sold states
US Nationwide Distribution in the states of CA, PA, and TX
Affected count
2
Manufactured in
2905 Northwest Blvd Ste 40, Plymouth, MN, United States
Products
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2014Don't want to check this manually?
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