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Recall Observatory FDA recall evidence

Device product

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

Z-0548-2021

November 11, 2020

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 86845
Status
Terminated
Classification
Class II
Quantity
552 units
Official record key
device-enforcement:Z-0548-2021

Official wording

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

Code information: Rev Version B, Rev C and Rev D

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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