The Recall Desk
HighFDA (Devices)·Z-2595-2018·Announced 2018-08-08

Integra LifeSciences Recalls Mayfield Spine Table Adaptors Due to Fracture Risk

Integra LifeSciences is recalling 95 Mayfield Spine Table Adaptors because the knob assembly may fracture during use, posing a risk to patients.

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 structural defect in a medical device that could cause harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Integra LifeSciences Corp. is recalling 95 units of the Mayfield Spine Table Adaptor Radiolucent, Part Number A2600R. The device is intended to support patients during diagnostic examinations and surgical procedures where rigid support and X-ray imaging are required.

The recall is due to a potential for the knob assembly in the swivel adapter to fracture or break during use. This defect could compromise the stability of the patient support system.

The affected units were distributed worldwide, including nationwide in the United States and in various international markets. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.

The recalled product

Product
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R 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 Equipment
Hazard
Affected units
95

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 (20)

  • 56487
  • 57300
  • 57825
  • 58248
  • 59022
  • 59844
  • 61783
  • 61850
  • 62702
  • 63701
  • 64835
  • 66039
  • 66914
  • 68778
  • 81912
  • 85485
  • 86195
  • 88511
  • 1501445
  • 1664646

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 · structural failure

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