Z-1008-2025 Class II Ongoing
FDA device recall Z-1008-2025 was initiated by Integrity Implants Inc. on December 20, 2024 and is designated Class II. Reason for recall: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). The recall status is ongoing. Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
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).
Distribution Pattern
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