Reported Feb 21, 2018 · Terminated
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
AGC 2000 LP Patellalabeled as AGC Porous Patellar SMModel Number 150802
- Product UsageFor use in Total Knee Arthroplasty
- Lot codes and dates
- 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).
- Amount recalled
- 28 devices
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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