Device product
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Z-1943-2014
Product summary
- Event
- Event 68482
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1943-2014
Official wording
Reason: 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.
Code information: Lot C785241, Exp 4-2015
Distribution pattern: US Nationwide Distribution in the states of CA, PA, and TX
Derived failure modes
-
Labeling or packaging
Mislabeled