FDAClass IIDecember 16, 2020

Instruction Manual for Mayfield A2000 recall

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

Why was Instruction Manual for Mayfield A2000 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Rev Version B, Rev C and Rev D

Product
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N…
Recalling firm
Integra LifeSciences Corp.
Quantity
552 units
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.
Recall date
December 16, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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