FDA Device recall Z-2156-2020
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee pr…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee pr… 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-2156-2020 |
| 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: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
Reason
Potential presence of elevated endotoxin levels that exceed the specification limit
Identifiers
| code_info | Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550 |
|---|
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-2156-2020%22
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