Recall archive / FDA device enforcement
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, ... — FDA record Z-1651-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
- Reason
- 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)
- Classification
- Class II
- Recalling firm
- Tornier, Inc
- Quantity
- 5 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1651-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00846832015054, Batch Number CC0421265 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 30, 2025
- Recall initiation date
- Mar 3, 2025
- Center classification date
- Apr 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.