Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units
Integra LifeSciences is recalling 409 Mayfield Infinity XR2 Base Units because the knob assembly in the swivel adapter may fracture or break during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with a mechanical defect that could cause injury during use, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corp. is recalling 409 units of the Mayfield Infinity XR2 Base Unit, Part Number A2079. The 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 is being conducted 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 consumers should stop using the affected devices and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 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.
- Affected units
- 409
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)
- 57218
- 58242
- 59524
- 61083
- 61084
- 61533
- 61559
- 62801
- 63826
- 63949
- 65966
- 65967
- 66950
- 67912
- 70432
- 70564
- 74838
- 76382
- 78005
- 79436
Distribution
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.
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