Z-3008-2026 Class II Ongoing
FDA device recall Z-3008-2026 was initiated by AVID Medical, Inc. on July 9, 2026 and is designated Class II. Reason for recall: Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. The recall status is ongoing. Affected quantity: 78 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 kits
Product Description
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Reason for Recall
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Distribution Pattern
US Nationwide distribution in the states of MS, TX.
Code Information
Lot Code: Lot Number: 1654575 UDI: 10809160457887