Devices

Device Recall Howmedica HIp Stem

  • 모델명 / 제조번호(시리얼번호)
    Hip Fracture Stem # 3.5; Catalog number 6942-0-035; Lot codes: 7566701, 7819401, 7819402, 7819403, 7819405, 7869001, 7869002, 7869003, 7869004, 7869005, 7935701, 7935702, 7935704, 7999901, 7999902, 8152301, 8152302, 8152303, 8242501, 8850401, 8850402, 8850403, 8850404, 9503301, 9844801, 9844802, 9948201, 9948203, 10546201, 10546202, 10673501, 11090201, 11319301, 11319302, 11319303, 11369601, 11605702, 16033902, 16033903, 16165902, 16166001, 16840401, 16840402, 17289401, 17289402, 18448001, 18448002, 19131601, 10131602, 19490903, 19490904, 19834301.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Howmedica Hip Fracture Stem System || No. 3.5 Femoral Component || Uses No. 3 Fenestrated Plus || Sterile REF Catalogue #6942-0-035 || Made in Ireland
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

제조사

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall Howmedica HIp Stem
  • 모델명 / 제조번호(시리얼번호)
    Hip Fracture Stem # 1; Catalog Number 6942-0-010; Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204, 6660205, 7237401, 7237402, 7237403, 7237404, 7237405, 7934101, 7934102, 7934103, 7934104, 7934105, 8345801, 8345802, 8345803, 8345804, 9714001, 9911901, 9911902, 10420701, 10420702, 10756001, 11319201, 11369101, 11369102, 11369103, 11605201, 11605202, 13093201, 13093301, 13093302,13093401, 13093501, 13562501, 13562502, 13782001, 15550502, 16060001, 16060002, 16840301, 17289301, 17289302, 18448101, 18448102, 18448103, 18593901, 14413201R, P4FEA.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component, Fenestrated || Sterile || Made in Ireland
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Howmedica HIp Stem
  • 모델명 / 제조번호(시리얼번호)
    Hip Fracture Stem # 2: Catalog Number 6942-0-020; Lot Codes: 7237501, 7237502, 7237503, 7237505, 7600201, 7600202, 7662301, 7662302, 7662303, 7662304, 7692401, 7692402, 7692403, 7692406, 7805601, 7805602, 7805603, 7805604, 7934901, 7934902, 7944903, 7934904, 7999101, 7999102, 7999103, 7999104, 8152001, 8152002, 8152003, 8152004, 8152005, 8152006, 8152101, 8152102, 8152103, 8152104, 8241701, 8241702, 8241703, 8241704, 8241705, 8241706, 8345701, 8345702, 8345703, 8345704, 8478101, 8478102, 8478103, 8478104, 8569601, 8569602, 8632901, 8632902, 8633001, 8633101, 8633201, 8791103, 8791104, 8971301, 8993501, 8994801, 8995001, 8995601, 8995701, 9004401, 9004402, 9243601, 9243602, 9243603, 9400701, 9400702, 9400703, 9400704, 9400705, 9400706, 9475901, 9714101, 9714102, 9714104, 9911701, 9911702, 9911703, 9911705, 9911706, 9967201, 9967202, 9967203, 10353602, 10362901, 10420901, 10421001, 10585002, 10585003, 10585004, 10585005, 10585006, 10673301, 10673302, 10673303, 11064601, 11064602, 11064603, 11089903, 11089904, 11369301, 11369302, 11369303, 11436901, 11436902, 11605301, 11604302, 11791901, 11791902, 11791903, 11920901, 11920902, 11920903, 12084501,12084502, 12084503, 12084505, 12406801, 12406802, 12406803, 12406901, 12947501, 12947502, 12947503, 12947504, 13184201, 13184202, 13184203, 13184204, 13184301, 13412201, 13412202, 13412203, 13782102, 13782104, 13793501, 13973502, 13984701, 13984702, 13984703, 14108402, 14196701, 14196702, 14274601, 14368101, 14368102, 14368103, 15485101, 15485102, 15485103, 15485104, 15485105, 15668701, 15668702, 15953601, 15953602, 15953603, 15953604, 15953605, 15953606, 16059801, 16059802, 16059803, 16165601, 16203701, 16203702, 16499401, 16499402, 16499403, 16499404, 16937901, 16937902, 16937904, 17220101, 17220102, 17220103, 17220104, 17307801, 17307802, 17307804, 17658001, 17658002, 17658003, 17745201, 17745202, 17745203, 17969401, 17969402, 18320601, 18320602, 18448602, 18594101, 18594102, 18594601, 19246901, 19247001, 19247101, 19329001, 19329002, 19532501, 19532504, 19577101, 19577102,19826201, 19826203, 15953604R, 19329001R, 7805601R.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Howmedica Hip Fracture Stem System || No. 2 Femoral Component || Fenestrated || Sterile REF Catalogue #6942-0-020 || Made in Ireland
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Howmedica HIp Stem
  • 모델명 / 제조번호(시리얼번호)
    Hip Fracture Stem # 3; Catalog number 6942-0-030, Lot codes: 7238602, 7238603, 7238604, 7353002, 7353003, 7600501, 7600502, 7692501, 7692503, 7692504, 7692505, 7292506, 7935101, 7935102, 7935103, 7999701, 7999702, 7999703, 7999801, 7999803, 8152201, 8152203, 8152204, 8152205, 8152206, 8152207, 8152208, 8241801, 8241802, 8242101, 8252102, 8242103, 8345503, 8345504, 8531601, 8531901, 8532001, 8532301, 8532401, 8532501, 8532601, 8643301, 8643302, 8643303, 8643304, 8643305, 8850801, 8850802, 8850901, 8850902, 8850903, 9011101, 9044301, 9044302, 9044303, 9044304, 9090101, 9124401, 9400801, 9400802, 9400803, 9503202, 9574801, 9911802, 9911803, 9948101, 9948102, 10164601, 10164602, 10212501, 10317501, 10353702, 10353703, 10917801, 10917802, 10917803, 10917804, 10917806, 11064501, 11064503, 11092701, 11092702, 11092703, 11092704, 11092705, 11369401, 11369402, 11605501, 11607801, 12407001, 12407003, 12407005, 12407006, 12870602, 12870603, 12870604, 12947201, 12947202, 12947203, 13294601, 13294602, 13294603, 13294604, 13294605, 13294606, 13412101, 13412102, 13412103, 13412104, 13782202, 13782203, 13782204, 13782205, 14377903, 14412801, 14412804, 14412805, 14682701, 14682702, 14738901, 15236201, 15550301, 15550302, 15550303, 16059701, 16059703, 16059704, 16059705, 16059706, 16165503, 16499502, 16750801, 16937801, 16937802, 16937803, 16937804, 16937805, 16937806, 17540401 17540402, 17657902, 17657903, 17745101, 17842801, 17842802, 17842803, 18062101, 18062202, 18131401, 18131402, 18131403, 18448701, 18448702, 18594201, 18594202, 18594203, 18946901, 18946902, 19428801, 19673002, 19673003, 19673004, 19726201, 20304601, 20304602, 20304604, 20304607, 7023401R.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Howmedica Hip Fracture Stem System || No. 3 Femoral Component || Fenestrated || Sterile REF Catalogue #6942-0-030 || Made in Ireland
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Howmedica HIp Stem
  • 모델명 / 제조번호(시리얼번호)
    Hip Fracture Stem # 4; Catalog number 6942-0-040; Lot codes: 7567401, 7799201, 7868901, 7868902, 7868903, 7936001, 7936002, 8243001, 8243002, 9401001, 9948301, 9948302, 9948304, 14342101, 17596001, 17596002, 17810901, 17969201, 18062501, 18062502, 18062503, 8243003R, MPRTA.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Howmedica Hip Fracture Stem System || No. 4 Femoral Component || Fenestrated || Sterile REF Catalogue #6942-0-040 || Made in Ireland
  • Manufacturer
    Stryker Howmedica Osteonics Corp.