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Lower risk Medical device recall · FDA · Published December 20, 2024

Repeater Bone Tamp (ASY-001: Rev A) recall due to bone funnel incompatibility

Integrity Implants recalls Repeater Bone Tamps (model ASY-00132, Rev A) due to incompatibility with bone funnels (Rev C). Affected users should contact the company for details.

🇺🇸 FDA recall #Z-1008-2025Medical deviceIntegrity Implants ›
Take action

Contact the company

Recalling firmIntegrity Implants Inc.354 Hiatt Dr · Palm Beach Gardens, FL 33418-7236
✎ GovInfoNow plain-language explainer

Integrity Implants is recalling Repeater Bone Tamps (model ASY-00132, Rev A) because they may not work properly with bone funnels (Rev C) during spinal fusion surgery. This incompatibility could lead to improper bone graft placement. Read more at govinfonow.com/recall/53203-repeater-bone-tamp-asy-001-rev-a-recall-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/53203-repeater-bone-tamp-asy-001-rev-a-recall-due-to · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1008-2025

Cite this page

“Repeater Bone Tamp (ASY-001: Rev A) recall due to bone funnel incompatibility.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53203-repeater-bone-tamp-asy-001-rev-a-recall-due-to. Based on FDA recall #Z-1008-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2025%22&limit=1).

Integrity Implants Inc. recalled Repeater Bone Tamp model ASY-00132 due to incompatibility between the bone tamp and bone funnels, the FDA said on Dec. 20, 2024. The voluntary Class II recall affects nine units distributed nationwide.

How to tell if you have it

  • Brand: Integrity Implants
  • Product Name: Repeater Bone Tamp
  • Model/Catalog Number: ASY-00132
  • Lot Number: 03200045
  • UPC: 00810004721906

The hazard

The recall is due to the incompatibility of bone tamp (Rev A) and bone funnels (Rev C), according to the FDA. 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.

Context

GovInfoNow's records show Integrity Implants Inc. has three other recalls on record since Feb. 27, 2018. Other recent recalls of similar products include LineSider Spinal Screws Recall (Aug. 3, 2022), LineSider Spinal System 5.5/6.0mm Recall (Jan. 27, 2022) and FlareHawk Interbody Fusion System IFU's Recall (Feb. 27, 2018). Other recent recalls of similar products include Encore Medical RSP Humeral Socket Insert Recall (Jan. 15, 2026), Straumann GM Helix Dental Implant Recall (July 13, 2026) and IsoTis OsteoBallast Spine Implants Recall (July 2, 2026).

How to tell if you have this one

Check for the model number ASY-00132 on the Repeater Bone Tamp. The software version is N/A, and the product was used with bone funnels (Rev C) in spinal fusion procedures.

  • Brand
    Integrity Implants
  • Product
    Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Integrity Implants for specific guidance on the recall and any necessary actions.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 8 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “U.S. Nationwide distribution in the states of CA, F, GA, KY, LA, MA, MD, TN and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Kentucky, Louisiana, Maryland, Massachusetts, Tennessee, Virginia.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: Dec 20, 202412. FDA classified it Class II: Jan 22, 202523. Published in FDA’s Enforcement Report: Jan 29, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is there a risk of serious injury?

The recall indicates a potential issue with surgical effectiveness, but no specific injury risks are mentioned in the official notice.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1008-2025 (December 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1008-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA