FDA Device recall Z-1591-2024
Identity Imprint PS Tibial Tray Size 4: Lot 540287
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Identity Imprint PS Tibial Tray Size 4: Lot 540287 by Conformis, citing size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1591-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-11 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Conformis |
| Distribution | US |
Product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Reason
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Identifiers
| code_info | Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2024%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.