Recall of Greatbatch, Offset Cup Impactor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greatbatch Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75043
  • Event Risk Class
    Class 1
  • Event Number
    Z-0367-2017
  • Event Initiated Date
    2016-08-02
  • Event Date Posted
    2016-11-29
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-07-27
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Impactor - Product Code HWA
  • 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.

Device

  • Model / Serial
    Lot Number 30491 34897 2495656 2500095 2530283 2543053 2561976 2564518 2565790 2661673 2742720 2742725 2742726 2750445 2750447 2789308 2794360 2799474 2799475 2816992 2828788 2832952 2842658 2853782 2927152 2970762 2970798 3016939 3018991 3018992 3018993 3029352 3058553 3087813 3138763 3148504 3166474 3172918 3187998 3188004 3252224 3270048 3275306 5780001 2233370001 2233670001 2242190001 2259200001 2259210001 2271650001 2299480001 2299490001 2315880001 2315890001 2315900001 2315910001 2315920001 2322180001 2362520001 2363250001 2371900001 2371910001 2371920001 2371950001 2378420001 2459710001 2471740001 2487360001 2490460001 2491700001 2491710001 2504910001 2504930001 2504950001 2516110001 2518340001 2518350001 2518370001 2528690001 2553410001 2553440001 2553450001 2559210001 2566230001 2595380001 2627950001 2665630001 2724230001 2725870001 2725880001 2745160001 2766420001 2781250001 2782010001 3006450001 3007860001 3029980001 3037400001 3037470001 3038530001 3038560001 3038700001 3038720001 3038730001 3038740001 3038750001 3038760001 3038790001 3038800001 3038810001 3038820001 3038830001 3038840001 3038850001 3038860001 3039320001 3039330001 3046100001 3046200001 3060700001 3061130001 3061390001 3061930001 3062700001 3065930001 3066030001 3066060001 3068430001 3083790001 3086350001 3091750001 3092720001 3092730001 3093900001 4006680001 4007350001 4007560001 6342540001 6411410001 6411450001 7004290001 7008770001 7010540001 7011200001 7011240001 7014640001 7019390001 7022800001 7022810001 7023900001 7023900002 7032220001 7032230001 7033140001 7033830001 7036020001 7043510001 7046530001 7047580001 7054290001 7055180001 7064180001 7064340001 7067270001 7067280001 7068200001 7068300001 7068310001 7070520001 7072060001 7072070001 7072370001 7072370001 7072380001 7072610001 7075380001 7084500001 7085220001 7085620001 7085660001 7094580001 7094640001 7095080001 7095400001 7095410001 7097350001 7099830001 7100040001 7102740001 7102860001 7103040001 7103110001 7103350001 7103370001 7103380001 7103390001 7103560001 7104750001 7105030001 7105130001 7105350001 7105680001 7105720001 7106840001 7107610001 7108540001 7110290001 7112630001 7112770001 7113670001 7115160001 7116610001 7116620001 7116970001 7116980001 7117140001 7117150001 7117350001 7117490001 7117750001 7117760001 7117800001 7118530001 7118960001 7119760001 7119790001 7119800001 7124570001 7124580001 7124840001 7124940001 7126400001 7127770001 7128600001 7132050001 7132570001 7136610001 7139090001 7143650001 7143700001 7143710001 7145140001 7147570001 7148710001 7151430001 7152660001 7152930001 7153580001 7153610001 7153840001 7153850001 7153860001 7153870001 7155930001 7157020001 7157820001 7158050001 7161200001 7162790001 7165980001 7168000001 7168010001 7168270001 7170610001 7172520001 7175480001 7176040001 7176290001 7176330001 7177340001 7177350001 7177360001 7177370001 7179510001 7180460001 7180910001 7187030001 7187110001 7187650001 7187880001 7187890001 7188410001 7188420001 7188510001 7188520001 7190750001 7204710001 7206200001 7206930001 7212370001 7212490001 7215880001 7221210001 7228670001 7233210001 7233470001 7233490001 7234170001 7234260001 7234750001 7235840001 7236740001 7237910001 7241550001 7243420001 7244460001 7244900001 7252070001 7252330001 7253080001 7253090001 7253200001 7255070001 7255430001 7259520001 7261980001 7263100001 7264550001 7265500001 7266960001 7268590001 7269650001 7269660001 7273870001 7276290001 7276350001 7277140001 7284380001 7284420001 7284540001 7285000001 7285150001 7285170001 7285260001 7285660001 7285780001 7285820001 7288860001 7290770001 7290780001 7290900001 7307910001 7307920001 7307930001 7307940001 7307950001 7307960001 7307970001 7307980001 7307990001 8181080001  1003292 149467 2225930001 2233670001-62 2259190001 255441 2740689 2822781 2824203 2827399 2827401 2840353 2846027 2846037 3037410001 & 3037420001 3037430001 & 3037440001 3037450001 & 3037460001 385228 446559 468474 493607 502998 520684 565663 573358 600359 682102 701817 701838 711367 7120480001 7124590001 7124600001 7124610001 7132510001 7144330001 7144340001 7144350001 7148720001 7149430001 7153590001 & 7153600001 7177130001 7188440001 7212390001 7234560001 7234570001 7242420001 7242430001 7245010001 7245020001 7245030001 7255380001 7255390001 7255400001 7255410001 7263030001 7263040001 7267070001 7267950001 7267960001 7267970001 7267980001 7267990001 743422 773568 799699 841060 847862 877907 892823 968916 991034 CIDO00 DIAP00 MCT705-05A178 MCT705-07D851 MCT705-07D851 MCT705-09B220 MCT705-10F633 MS1063 No Lot Code OF-002-29515-0001 OF-002-32530-0001 OF-002-41119-0001 OF-002-42944-0001 OF-002-44825-0001 OF-002-44826-0001 OF-002-45448-0001 OF-002-45665-0001 OF-002-46173-0001 OF-002-49050-0001 OF-002-50500-0001 OF-002-50501-0001 OF-002-53569-0001 OF-002-58260-0001 OF-002-61715-0001 OF-002-72372-0001 OF-002-72373-0001 OF-002-72420-0001 OF-002-75542-0001 OF-003-01045-0001
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Manufacturer Parent Company (2017)
  • Source
    USFDA