Integra recalls MAYFIELD Infinity XR2 Base Unit adaptors (part A2600R) due to potential knob fracture during use. Affected units sold from 2018-2023; check serial numbers listed.
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 adaptors (part A2600R) because the knob assembly might break during use. This could cause injury if the device becomes unstable during medical procedures.
The knob assembly in the swivel adapter can fracture during use, potentially causing the device to become unstable. This instability could lead to injury if the device moves unexpectedly during medical procedures.
Medical professionals using the MAYFIELD Infinity XR2 Base Unit adaptors for spinal procedures are most at risk. Patients undergoing imaging or surgery with this device may also be affected.
Check for the part number A2600R on the MAYFIELD Infinity XR2 Base Unit. Units sold between 2018 and 2023 with serial numbers listed in the recall notice are affected.
Look for the serial numbers listed in the recall notice (e.g., 56487, 57300) on the device.
Reach out to Integra LifeSciences Corp. directly for specific guidance on affected units.
The recall affects medical devices used by healthcare professionals during procedures, not patients directly.
Check for the part number A2600R and serial numbers listed in the recall notice (e.g., 56487, 57300).
The recall does not require immediate stop use; medical staff should monitor for knob fractures during procedures.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2595-2018 — Integra Integra Hello, I own a Integra that is covered by recall Z-2595-2018 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.
