Z-2244-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- June 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 626 units
Product Description
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Reason for Recall
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Distribution Pattern
Domestic: CA, IL, MD, OH, PA, TX, WA.
Code Information
Model No. MAMC228-13, MAMC228-14, MAMC228-15; UDI: 10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046; Kit Lot No. 1576797, 1577255, 1586536, 1606044, 1607044, 1607825, 1615452, 1621487, 1621488, 1638247, 1639254, 1647833.