BEUDAMED
    FDA Enforcement Class II Terminated

    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.

    Recall: Z-0534-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0534-2015
    Event ID
    69471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    September 8, 2014
    Classification Date
    December 8, 2014
    Termination Date
    November 29, 2017
    Address
    626 Cooper Ct, N/A, Schaumburg, IL, 60173-4537, United States

    Description

    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.

    Reason

    The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

    Code Info

    1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Boss Instruments Item Number: 46-5195; Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4"; Surgical Direct Item Number: SD16450.100; Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4"; Surgipro Item Number: SPGU-4570; Lot Number: 060810.

    Distribution

    Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

    Quantity

    81 clamps