# FDA recall Z-1008-2025

> **Integrity Implants Inc.** · Class II · device recall initiated 2024-12-20.

## 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

- **Recall number:** Z-1008-2025
- **Recalling firm:** Integrity Implants Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1008-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1008-2025. Source: US FDA. Licensed CC0.

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