AGC 2000 LP Patella recalled over mold contamination
- Recall date
- August 25, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Zimmer Biomet, Inc. recalls AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arth…
- Recall number
- Z-0628-2018
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- US Nationwide Distribution to IN, MO, NY, TX.
Why it was recalled
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
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