Integra recalls MAYFIELD Infinity XR2 Low Profile Base Unit (Part A2079A) due to potential knob assembly fracture during use. Affected units may cause injury during medical procedures.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Integra is recalling its MAYFIELD Infinity XR:2 Low Profile Base Unit (Part A2079A) because the knob assembly in the swivel adapter could fracture during use. This poses a risk of injury during medical procedures where the device is used to support patients.
The knob assembly in the swivel adapter may fracture during use, potentially causing injury to the patient or medical staff. This could happen when the device is used to support a patient during X-ray procedures or surgical operations where positional stability is critical.
Medical professionals using the device for patient support during diagnostic or surgical procedures are most at risk. Patients receiving care with this equipment could also be affected.
Check for the product name 'MAYFIELD Infinity XR2 Low Profile Base Unit' with part number A2079A. This device is used in medical settings for patient support during X-ray procedures and surgeries.
Inspect the knob assembly in the swivel adapter for signs of damage or cracks.
The recall states there is a potential for the knob assembly to fracture during use, so it is not safe to use without checking for damage.
The recall does not specify a remedy, so you should check for damage and contact Integra LifeSciences Corp. for further instructions.
Look for the product name 'MAYFIELD Infinity XR2 Low Profile Base Unit' with part number A2079A, which is used in medical settings for patient support during X-ray procedures and surgeries.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2594-2018 — Integra Integra Hello, I own a Integra that is covered by recall Z-2594-2018 from Integra. 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.
