Z-1347-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 kits
Product Description
TOTAL HIP PACK , Model No SMTH06O SMTH06P
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Distribution Pattern
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072163882 00191072229601 Lots 969241 928241 70-051508 70-052517