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Use caution Medical device recall · FDA · Published May 12, 2020

XTANT Medical Irix-C Forceps Inserter Recall: Fractured Strike Plate Hazard

XTANT Medical recalls Irix-C Forceps Inserter devices with product code T066-0059/ M697T06600591 due to risk of strike plate fracturing from unsatisfactory welds.

🇺🇸 FDA recall #Z-2500-2020Medical deviceXTANT Medical ›
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Recalling firmXTANT Medical664 Cruiser Ln · Belgrade, MT 59714-9719
✎ GovInfoNow plain-language explainer

XTANT Medical is recalling Irix-C Forceps Inserter devices with product code T066-0059/ M697T06600591 because the strike plate can fracture from unsatisfactory welds. This could lead to device failure during medical procedures. Read more at govinfonow.com/recall/65188-xtant-medical-irix-c-forceps-inserter-recall-fractured-strike-plate.

Source Summary by GovInfoNow · govinfonow.com/recall/65188-xtant-medical-irix-c-forceps-inserter-recall-fractured-strike-plate · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2500-2020

Cite this page

“XTANT Medical Irix-C Forceps Inserter Recall: Fractured Strike Plate Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65188-xtant-medical-irix-c-forceps-inserter-recall-fractured-strike-plate. Based on FDA recall #Z-2500-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2500-2020%22&limit=1).

XTANT Medical voluntarily recalled the Irix-C Forceps Inserter on May 12, 2020, according to the FDA. The device poses a fracture hazard due to unsatisfactory welds. The recall was announced by the Food and Drug Administration.

How to tell if you have it

  • Brand: XTANT Medical
  • Product: Irix-C Forceps Inserter
  • Product Code/UDI: T066-0059/ M697T06600591
  • Lot: XS1920458A
  • Quantity: 4 units

The hazard

The strike plate may fracture off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld, according to the FDA.

Context

GovInfoNow's records show XTANT Medical has issued two other recalls since September 30, 2020, including a December 29, 2021 recall for X060-0270 8mm Titanium Insert due to misaligned plates and a September 30, 2020 recall for cervical implants with incorrect titanium grade labels. Other recent recalls of similar products include Olympus PKS Cutting Forceps (February 25, 2026) and Stryker XCEL Bladeless Trocar W/Stability Sleeve (August 19, 2026).

How to tell if you have this one

Check for product code T066-0059 or UDI M697T06600591 on the device. The lot number XS1920458A is also associated with this recall.

  • Brand
    XTANT Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Verify the product code T066-0059 or UDI M697T06600591 and lot number XS1920458A on the device.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: yesWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “AZ, TX and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Texas, West Virginia.

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: May 12, 202012. FDA classified it Class II: Jul 4, 202023. Published in FDA’s Enforcement Report: Jul 15, 202034. FDA terminated the recall: Mar 19, 2021420202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-2500-2020 (May 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2500-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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