FDA recall Z-1008-2025

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 for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-12-20

Report date

2025-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Beach Gardens, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2025