FDAFDA · Food and drugs·Recall number Z-0627-2018
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Published February 21, 2018 · Recall initiated: August 25, 2017
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
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US Nationwide Distribution to IN, MO, NY, TX.
- Lot
- Model No. 150802: Lot No. 305330 (UDI (01)00880304240230(17)220506(10)305330), 305340 ((01)00880304240230(17)220506(10)305330), 305350 ((01)00880304240230(17)220517(10)305350), 356750 ((01)00880304240230(17)220523(10)356750).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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