The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0548-2021·Announced 2020-12-16

Integra Recalls Mayfield A2000 Skull Cap Instruction Manual

Integra LifeSciences Corp. is recalling 552 instruction manuals for the Mayfield A2000 Skull Cap to correct inaccurate illustrations.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is limited to documentation accuracy (mis-labeling/illustration error) rather than a direct physical defect in the device itself, fitting the criteria for a moderate severity score.

Plain-English summary

Integra LifeSciences Corp. is recalling 552 units of the Instruction Manual for the Mayfield A2000 Skull Cap. The product is intended for rigid skeletal fixation during neurosurgical procedures. The recall involves specific revisions (Rev Version B, Rev C, and Rev D) of the manual.

The recall was initiated to provide a revised instruction manual that reflects the most accurate illustration for the Mayfield Skull Clamp A2000 Position Diagram. The source text does not report any illnesses, injuries, or deaths associated with this recall.

The affected manuals were distributed worldwide, including in the United States, Australia, Brazil, China, Hong Kong, India, Sri Lanka, Mexico, the Philippines, and Trinidad. Consumers and healthcare facilities should stop using the affected manuals and contact the manufacturer for a replacement.

The recalled product

Product
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Neurosurgical Instrument
Hazard
Affected units
552

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 (2)

  • Rev Version B
  • Rev C and Rev D

Distribution

Distributed nationwide across the United States.

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