FDA Device recall Z-2153-2020
Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infus…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infus… 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-2153-2020 |
| 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: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis
Reason
Potential presence of elevated endotoxin levels that exceed the specification limit
Identifiers
| code_info | Lot Numbers: UDI Number 294130 Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17…Lot Numbers: UDI Number 294130 Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130 509970 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970 509990 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990 175980 Knees Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM (01)00880304438354(17)220114(10)175980 294130R Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130R 509970R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970R 509990R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990R |
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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-2153-2020%22
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