Food, drugs, devices › Integrity Implants Inc.
Device recall: Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descripti
Integrity Implants Inc. (Palm Beach Gardens, FL) initiated this device recall on 20 Dec 2024; FDA lists 1 product record under event 96099, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Integrity Implants Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integrity Implants Inc., Palm Beach Gardens, FL.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1008-2025 | 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.… | 9 | Class II | Ongoing | 29 Jan 2025 |
Context
Other enforcement events for Integrity Implants Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Aug 2022 | LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N | Device | Class II | 1 |
| 27 Jan 2022 | LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw | Device | Class II | 3 |
| 27 Feb 2018 | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product | Device | Class II | 1 |
All 4 events for Integrity Implants Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.