CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
N/A Repeater Bone Tamp recalled by Integrity Implants
Integrity Implants is recalling N/A Repeater Bone Tamp, distributed nationwide in the US. The recall was initiated on 20 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1008-2025
- FDA event ID
- 96099
- Recalling firm
- Integrity Implants, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2024
- FDA classified
- 22 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 20 Dec 2024 | Recall initiated by company | |
| 22 Jan 2025 | Classified by FDA | +33 days |
| 29 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
Nationwide CaliforniaGeorgiaKentuckyLouisianaMassachusettsMarylandTennesseeVirginia
Questions about this recall
Why was it recalled?
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Which lots are affected?
Lot Code: Part Number: ASY-00132 Lot Number: 03200045 UDI Number: (01)00810004721906(10)03200045
Where was it sold?
U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Integrity Implants
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | LineSider Spinal System, Non-mod Standard - Dual Lead recalled | Integrity Implants | Other | Nationwide |
| Device | CLASS II | LineSider Spinal System pedicle screws, Non-mod Standard recalled | Integrity Implants | Other | 5 states |
| Device | CLASS II | LineSider Spinal System, Non-mod MIS - Dual Lead, Cannulated recalled | Integrity Implants | Other | Nationwide |
| Device | CLASS II | LineSider Spinal System, Non-mod Standard - Dual Lead, Cannulated recalled | Integrity Implants | Other | Nationwide |
| Device | CLASS II | FlareHawk Interbody Fusion System recalled by Integrity Implants | Integrity Implants | Other | Nationwide |
Other Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |