Z-1651-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- March 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
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)
Distribution Pattern
OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany
Code Information
GTIN 00846832015054, Batch Number CC0421265