BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0548-2021 · Reported December 16, 2020

    Enforcement

    Recall Number
    Z-0548-2021
    Event ID
    86845
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2020
    Initiation Date
    November 11, 2020
    Classification Date
    December 8, 2020
    Termination Date
    June 17, 2021
    Address
    1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States

    Description

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

    Reason

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

    Code Info

    Rev Version B, Rev C and Rev D

    Distribution

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

    Quantity

    552 units