FDA Device recall Z-2147-2020
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis 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-2147-2020 |
| 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: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Reason
Potential presence of elevated endotoxin levels that exceed the specification limit
Identifiers
| code_info | Lot Numbers: UDI Number 292720 (01)00880304006492(17)211222(10)292720 |
|---|
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-2147-2020%22
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