The Recall Desk
HighFDA (Devices)·Z-1008-2025·Announced 2025-01-29

Repeater Bone Tamp Recalled for Component Incompatibility in Spinal Fusion

Integrity Implants Inc. is recalling Repeater Bone Tamp devices (Model ASY-00132) due to incompatibility between Revision A bone tamps and Revision C bone funnels used in spinal fusion procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device recall for surgical implants with no reported illnesses or injuries. Component incompatibility in a risk-of-harm product qualifies as High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Integrity Implants Inc. is recalling Repeater Bone Tamp devices, Model ASY-00132. These devices are cylindrical shafts used to push bone graft material through a bone funnel into the FlareHawk interbody fusion device during spinal fusion procedures. The recall is due to incompatibility between the bone tamp (Revision A) and the bone funnels (Revision C).

Nine units with lot number 03200045 were distributed nationwide in California, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Maryland, Tennessee, and Virginia. Healthcare facilities and physicians with affected devices should verify component revisions and contact Integrity Implants Inc. regarding this recall.

The recalled product

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 d
Manufacturer
Integrity Implants Inc.
Category
Medical Device — Spinal Fusion Implant
Hazard
  • component-incompatibility
  • device-malfunction

Distribution

Distributed nationwide across the United States.

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