FDA Medical devices recall ·
N/A Product Name: Repeater Bone Tamp Model recall
- Recall number
- Z-1008-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Integrity Implants Inc.
354 Hiatt Dr, Palm Beach Gardens, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045
Distribution
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
States: California Georgia Kentucky Louisiana Massachusetts Maryland Tennessee Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1008-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.