XTANT Medical recalls Irix-C Forceps Inserter devices with product code T066-0059/ M697T06600591 due to risk of strike plate fracturing from unsatisfactory welds.
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
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.
The strike plate can fracture due to weak welds, potentially causing the device to fail during medical procedures. This could lead to complications if the device malfunctions while in use.
Healthcare professionals using these devices for medical procedures are most at risk. Patients receiving procedures with these devices may also be affected.
Check for product code T066-0059 or UDI M697T06600591 on the device. The lot number XS1920458A is also associated with this recall.
Verify the product code T066-0059 or UDI M697T06600591 and lot number XS1920458A on the device.
The strike plate can fracture from unsatisfactory welds, potentially causing device failure during medical procedures.
The recall record does not specify a remedy or action steps for affected devices.
The recall indicates a risk of device failure during medical procedures, but the record does not specify injury details.
We’ve drafted a message you can send XTANT Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2500-2020 — XTANT Medical XTANT Medical Hello, I own a XTANT Medical that is covered by recall Z-2500-2020 from XTANT Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
