Class II

Medical Device Recall: 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 ma

Integrity Implants Inc. · December 20, 2024

Reason for Recall

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

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

9

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1008-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.