Integra LifeSciences recalls MAYFIELD Infinity XR2 Base Unit-Extended (Part A2079E) 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 LifeSciences is recalling the MAYFIELD Infinity XR2 Base Unit-Extended (Part A2079E) because the swivel adapter's knob could break during use. This poses a risk of injury during medical procedures where the device supports a patient.
The knob assembly in the swivel adapter can fracture during use, potentially causing injury to the patient or medical staff. This risk occurs when the device is used for procedures requiring positional freedom and X-ray imaging.
Medical professionals using the device during diagnostic or surgical procedures are most at risk. Patients receiving treatment with this equipment may also be affected.
Check for the product name 'MAYFIELD Infinity XR2 Base Unit-Extended' with part number A2079E. The device is used in medical settings for supporting patients during X-ray procedures.
Inspect the swivel adapter knob for cracks or signs of damage before use.
The device may be safe if the knob is intact, but there is a risk of fracture during use. Always check for damage before use.
Look for the product name 'MAYFIELD Infinity XR2 Base Unit-Extended' with part number A2079E.
Inspect the swivel adapter knob for cracks or damage. If damaged, stop using it immediately.
We’ve drafted a message you can send MAYFIELD to request your refund or repair — edit it as you like.
Subject: Recall Z-2593-2018 — MAYFIELD MAYFIELD Hello, I own a MAYFIELD that is covered by recall Z-2593-2018 from MAYFIELD. 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.