Identity Imprint PS Tibial Tray Size 4: Lot 540287 — Class II medical device recall Z-1591-2024
Ongoing recall by Conformis, Inc., reported 2024-04-24, distributed nationwide. Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540
| Recall number | Z-1591-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2024-03-11 |
| Classified | 2024-04-17 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Lot numbers | 540287 |
| Model numbers | TPS-301-T04S |
Product
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1591-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.