Integra recalls MAYFIELD Infinity XR2 Base Unit (Part A2079) due to potential knob assembly fracture during use. This device supports patients during X-ray procedures. Affected units may need repair or replacement.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Integra is recalling its MAYFIELD Infinity XR2 Base Unit (Part A2079) 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 recall affects medical devices used in X-ray imaging and surgical settings.
The knob assembly in the swivel adapter may break during use, which could cause the device to become unstable. This instability might lead to injury if the device shifts unexpectedly during medical procedures requiring patient support.
Medical professionals using the MAYFIELD Infinity XR2 Base Unit for X-ray procedures or surgeries are most at risk. Patients receiving treatment with this device could also be affected if the unit malfunctions.
Check for the part number A2079 on the MAYFIELD Infinity XR2 Base Unit. The device is used in medical settings for X-ray procedures and surgical support. Units sold between 2019 and 2023 are likely affected.
Inspect the swivel adapter's knob assembly for cracks or damage that could cause it to break during use.
Reach out to Integra LifeSciences Corp. for guidance on whether your unit needs repair or replacement.
The recall indicates a potential risk of the knob assembly fracturing during use, so it's recommended to check for damage and contact Integra for guidance.
Look for the part number A2079 on the MAYFIELD Infinity XR2 Base Unit. The device is used in medical settings for X-ray procedures and surgical support.
Check the knob assembly for damage and contact Integra LifeSciences Corp. for instructions on repair or replacement.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2592-2018 — Integra Integra Hello, I own a Integra that is covered by recall Z-2592-2018 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.