stryker Latitude EV HUMERAL REVISION STEM TRIAL — Class II medical device recall Z-1651-2025
Ongoing recall by Tornier, Inc, reported 2025-04-30. A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103,
| Recall number | Z-1651-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2025-03-03 |
| Classified | 2025-04-22 |
| Reported by FDA | 2025-04-30 |
| Countries outside the US | AU, CO, DE, GB, SE |
| Quantity | 5 units |
| UPC / GTIN / UDI-DI | 00846832015054 |
| Lot numbers | CC0421265 |
| Model numbers | 9030103 |
Product
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Reason for recall
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
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-1651-2025. 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.