TOTAL HIP PACK , Model No SMTH06O SMTH06P
FDA Recall #Z-1347-2025 — Class II — February 6, 2025
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.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
24 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072163882 00191072229601 Lots 969241 928241 70-051508 70-052517
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated