FDAFDA · Food and drugs·Recall number Z-1943-2014
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Published July 9, 2014 · Recall initiated: June 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Blue Belt Technologies MN
- Distributor
- US Nationwide Distribution in the states of CA, PA, and TX
- Lot
- Lot C785241, Exp 4-2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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