The Recall Desk
SevereFDA (Devices)·Z-2594-2018·Announced 2018-08-08

Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units Due to Fracture Risk

Integra LifeSciences is recalling Mayfield Infinity XR2 Low Profile Base Units because the knob assembly in the swivel adapter may fracture or break during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or structural defects are assigned a score of 4 (Severe).

Plain-English summary

Integra LifeSciences Corp. is recalling the Mayfield Infinity XR2 Low Profile Base Unit, Part Number A2079A. This medical device is intended to support patients during diagnostic examinations and surgical procedures where rigid support between the surgical table and headrest or skull clamp is necessary, and where X-ray imaging modalities are used.

The recall was initiated because there is a potential for the knob assembly in the swivel adapter to fracture or break during use. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected units were distributed worldwide, including nationwide in the United States and in countries such as Australia, Canada, China, and Japan. Healthcare facilities and users should stop using the affected base units and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A 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
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Support Equipment
Hazard
Affected units
1

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 (1)

  • CD-0436

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 →

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