Device recall
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
- Recall number
- Z-0092-2027
- Event id
- 99808
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Oct 7, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- Product may be potentially contaminated with a lubricant used during the manufacturing process.
- Root cause
- Process change control
- Quantity
- 144
- Code info
- 1. Model/Item Number (Kit): SAMM064-27; UDI-DI: 10809160439708; Kit Lot Numbers: 1657586, 1658104, 1671251; 2. Model/Item Number (Kit): SAMM064-28; UDI-DI: 10809160516201; Kit Lot Numbers: 1698700; Recalled Supplier Component (in kit): A303416A; Recalled Supplier Lot Number (in kit): NGKU1749, NGKV0359;
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States