CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report

Instruction Manual for Mayfield A2000 Skull Cap recalled

Integra LifeSciences is recalling Instruction Manual for Mayfield A2000 Skull Cap, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRev Version B, Rev C and Rev D

Quantity recalled552 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0548-2021
FDA event ID: 86845
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2020
FDA classified: 8 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

11 Nov 2020	Recall initiated by company
8 Dec 2020	Classified by FDA	+27 days
16 Dec 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

Product as listed by the FDA

Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.

Nationwide

Questions about this recall

Why was it recalled?

Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

Which lots are affected?

Rev Version B, Rev C and Rev D

Where was it sold?

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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