Integrity Implants Inc. recalls Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descript…

Recall date

December 20, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1008-2025

FDA classification

Class II

Brand / firm

Integrity Implants Inc.

Sold / distributed

U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.

Why it was recalled

Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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