Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog… — Class II medical device recall Z-1008-2025
Ongoing recall by Integrity Implants Inc., reported 2025-01-29, distributed nationwide. Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
| Recall number | Z-1008-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integrity Implants Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2024-12-20 |
| Classified | 2025-01-22 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 9 |
| UPC / GTIN / UDI-DI | 00810004721906 |
| Lot numbers | 03200045 |
| Model numbers | ASY-00132 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1008-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.