Device recall
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
- Recall number
- Z-3007-2026
- Event id
- 99527
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- AVID Medical, Inc.
- Report date
- Sep 2, 2026
- Posted
- Aug 21, 2026
- Initiated
- Jul 9, 2026
- Center classification date
- Aug 21, 2026
- Product code
- LRO
- Device type
- General Surgery Tray
- Reason
- Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Root cause
- Labeling Change Control
- Quantity
- 78 kits
- Code info
- Lot Code: Lot Number: 1649979 UDI: 10809160457887
- Distribution
- US Nationwide distribution in the states of MS, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Toano, VA, United States