FDA Device recall Z-0899-2022
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
- FDA Device
- Class II
- completed
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 by Conformis, citing incorrect tibial base plate implant packaged in kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0899-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-02-22 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Conformis |
| Distribution | MS |
Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Reason
Incorrect tibial base plate implant packaged in kit
Identifiers
| code_info | Serial Number: 0496242 UDI: M572TPS3011113011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0899-2022%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.