Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Vers...
FDA Recall #Z-1008-2025 — Class II — December 20, 2024
Product Description
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No
Reason for Recall
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Recalling Firm
Integrity Implants Inc. — Palm Beach Gardens, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9
Distribution
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
Code Information
Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated