SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
FDA Recall #Z-1360-2025 — Class II — February 6, 2025
Product Description
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
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
106 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072179753 Lots 939241 88241 70-052063 70-052618A 70-053157
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated