The Recall Desk
HighFDA (Devices)·Z-2593-2018·Announced 2018-08-08

MAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk

Integra LifeSciences is recalling 17 MAYFIELD Infinity XR2 Base Units because the knob assembly may fracture during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Integra LifeSciences Corp. is recalling 17 units of the MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E. The device is intended to support patients during diagnostic examinations or surgical procedures where rigid support between the surgical table and headrest or skull clamp is necessary.

The recall is being issued because there is a potential for the knob assembly in the swivel adapter to fracture or break during use. The affected units were distributed nationwide in the United States and to various countries including Australia, Canada, China, and others.

Healthcare facilities and users should stop using the affected devices and contact the recalling firm for instructions on replacement or repair.

The recalled product

Product
MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Support Equipment
Hazard
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 69626
  • 78445
  • 81360
  • 1526205
  • 1560439
  • 1610839
  • 1527910
  • 1560448
  • 1621857
  • 1959100
  • 2012964

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Integra LifeSciences Corp.

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Same hazard · fracture

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