Device 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
Z-1008-2025
Product summary
- Event
- Event 96099
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-1008-2025
Official wording
Reason: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Code information: Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045
Distribution pattern: U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
Derived failure modes
-
Unknown
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).