BEUDAMED
    FDA Recall Terminated

    Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1 7650 255000110 T8143 803-t 1-103 Tl4384 EK-00200690 T1666t XEB227242 T9316 MIMP3100CHA04 Tl3642 500325 T10753 ~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl0861 MMP3100CHA04 T16427 MMP3100CHA04 T9894 :-. MMP3100CHA04 T12861 MMP3100CHA\041 T8088 2002CUPI T1661 1 T16611 Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.

    Recall: Z-0367-2017 · Initiated August 2, 2016

    Recall

    Recall Number
    Z-0367-2017
    Event Number
    75043
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 2, 2016
    Posted
    November 29, 2016
    Terminated
    July 27, 2017
    Address
    2300 Berkshire Ln N, Plymouth, MN, 55441-4575

    Description

    Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CHA62 Tll340 SHP9109.00010 T8043 ~ MMP3100CHA04 T17321 MMPP3100CHA04 T15311 GG920010029 T1 7650 255000110 T8143 803-t 1-103 Tl4384 EK-00200690 T1666t XEB227242 T9316 MIMP3100CHA04 Tl3642 500325 T10753 ~MMP3100CH04 T9348 ~ MMP3100CHA04 T13480 MMP3100CHA042 T10243 ~MIMP3001CHA08 Tll209 ~ MMP300CHA12 Tl0861 MMP3100CHA04 T16427 MMP3100CHA04 T9894 :-. MMP3100CHA04 T12861 MMP3100CHA\041 T8088 2002CUPI T1661 1 T16611 Standard Offset Cup Impactors are handheld, reusable surgical instruments used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. They are equipped with a suitable connection system to the acetabular cup (e.g. a thread) and can be supplied with a fixed or removable shock absorber. A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument.

    Reason

    On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU).

    Action

    Greatbatch sent an Urgent Medical Device letter dated August 2, 2016, via FedEx to all affected consignees. The letter described the Reason for Field Correction Action, Risk to Health, and Instructions to Customers. Advised consignees to" immediately inform those responsible for sterilization of the devices to utilize the updated sterilization instructions, and post the attached notice where it is clearly visible to personnel who perform sterilization activities". Also instructed consignees to notify their customers and to complete and return the Field Correction Action Response Form. For questions contact your local Greatbatch Medical representative or 1-763-951-8235 or e-mail FieldActionCenter @Greatbatch.com.

    Distribution

    Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGDOM, AUSTRALIA, AUSTRIA, BELGIUM, SWITZERLAND, NORWAY, SWEDEN, and TAIWAN.

    Quantity

    4478 (2906 US, 1572 OUS)