Events

Device Recall Stryker Orthopaedics Bone Screw 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
    52713
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2121-2009
  • 사례 시작날짜
    2009-06-26
  • 사례 출판 날짜
    2009-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83746
  • 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
    Screw, fixation, bone - Product Code HWC
  • 원인
    Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in astm standard for titanium surgical implants.
  • 조치
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Stryker Orthopaedics Bone Screw
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 2030-6540-1; 6.5 CANCELLOUS BONE SCREW 40mm EELMKE 17-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm EEJMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm EEKMKE 18-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm KKPMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm KKTMKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm LN6MKE 22-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm KKRMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm NNLMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm NMYMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm NNWMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 40mm WH1MKE 01-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm WH2MKE 02-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 163MLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 15WMLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 161MLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 15RMLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 162MLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm 15YMLE 07-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX2MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX4MLE 16-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX3MLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm AX1MLE 18-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm JKTMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm JKWMLE 21-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm JN3MLE 22-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm MR0MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm MPXMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm MPYMLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 40mm HW0MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HVXMME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HW6MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HW4MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm HW2MME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 40mm 12WMNE 07-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 3J3MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 3A9MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 3A8MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 788MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 789MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T6MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T4MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T7MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 7T5MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8J8MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8JDMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8NTMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8J9MNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8NPMNE 17-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm 8JAMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 40mm MER824 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER91D 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER825 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER91A 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MER91E 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXX 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXW 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXT 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDXV 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERDY0 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MERJA8 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 40mm MET042 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31L 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31N 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31M 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31P 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET31R 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET03Y 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET040 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET041 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET7DT 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET8YM 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METAM8 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET7DR 22-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METM1H 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METLM4 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METLM6 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm MET8YN 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METAMA 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 40mm METLM5 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm METMR6 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm METMR7 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MET7DV 06-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1L6 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1A0 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1L4 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1A1 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA634 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA691 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA60V 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA6LX 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA712 18-Jan-2014 6.5 CANCELLOUS BONE SCREW 40mm MHA1WM 25-Jan-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Stryker Orthopaedics Cancellous Bone Screw; || Dia 6.5 mm; Lnth: 40 mm; Sterile: || Made in the USA; || Stryker Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The bone screws are optional fixtures that may be used during knee and hip replacement procedures.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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