Integrity Implants Inc.: Device Recall
Recall #Z-1008-2025 · 12/20/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1008-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Integrity Implants Inc.
- Status
- Ongoing
- Date Initiated
- 12/20/2024
- Location
- Palm Beach Gardens, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
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 Pattern
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.