FDA Device recall Z-2150-2020
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67… 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-2150-2020 |
| 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: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
Reason
Potential presence of elevated endotoxin levels that exceed the specification limit
Identifiers
| code_info | Lot Numbers: UDI Number 443160 Knees Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM (01)00880304271869(17)…Lot Numbers: UDI Number 443160 Knees Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM (01)00880304271869(17)211230(10)443160 458440 Knees Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM (01)00880304271852(17)220105(10)458440 376090 Knees Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM (01)00880304436947(17)220113(10)376090 678080 Knees Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM (01)00880304436954(17)220119(10)678080 |
|---|
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-2150-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.