Recall Z-1008-2025— Integrity Implants Inc.
Class II · Ongoing
Class II FDA medical device recall by Integrity Implants Inc., initiated 2024-12-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C)..
- Recalling firm
- Integrity Implants Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-20
- Firm location
- Palm Beach Gardens, FL, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.