FDA Device recall Z-2154-2020
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM by Biomet, citing potential presence of elevated endotoxin levels that exceed the specification limit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2154-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-17 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
Reason
Potential presence of elevated endotoxin levels that exceed the specification limit
Identifiers
| code_info | Lot Numbers: UDI Number 508390 Vanguard Knee System, Series-A Standard Patella, 28 MM (01)00880304431638(17)211218(1…Lot Numbers: UDI Number 508390 Vanguard Knee System, Series-A Standard Patella, 28 MM (01)00880304431638(17)211218(10)508390; 309810 Vanguard Knee System, Series-A Standard Patella, 31 MM (01)00880304431317(17)211228(10)309810 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2154-2020%22
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