Events

Device Recall Trident 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    46691
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1173-2008
  • 사례 시작날짜
    2008-01-21
  • 사례 출판 날짜
    2008-06-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68363
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    hip prosthesis acetabular component - Product Code MEH
  • 원인
    Foreign material: some of the parts tested exceeded stryker orthopaedics internal acceptance criteria for manufacturing residuals.
  • 조치
    Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.

Device

Device Recall Trident
  • 모델명 / 제조번호(시리얼번호)
    540-11-40A TRIDENT PSL HA SOLID BACK 40mm 2469501A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601E 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 2469901A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 2469902A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3383301A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3383301C 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3452801A 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2468301A 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2468301D 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2485601A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102E 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3452501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 3088702A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2483203A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2925906A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2518502A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2926107A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2518601A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926003A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926008A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2518702A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2518704A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 3118502A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468901A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701E 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701E 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3088802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902F 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2503601A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3712001A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101D 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101E 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501E 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2551301A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2650901A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910902A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910903A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2990801A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445201A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445202A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701E 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001F 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001E 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911002A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911003D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911004A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911005A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911005D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2551901D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 3000001A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 5334001A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2503501A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201C 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201D 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2651201C 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2911201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3452901A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3452901D
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution.
  • 제품 설명
    Trident PSL HA Cluster: || 40 mm to 72 mm, hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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