Events

Device Recall Stryker Orthopaedics Cancellous 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-2117-2009
  • 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=83742
  • 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 Cancellous Bone Screw
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 2030-6516-1; 6.5 CANCELLOUS BONE SCREW 16mm KL0MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm LKWMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm KL2MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MJWMKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm LL3MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm LL1MKE 23-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm LKNMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm KKYMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MK1MKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MK0MKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MJYMKE 24-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MK2MKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm N00MKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MYYMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm MYXMKE 25-Jun-2013 6.5 CANCELLOUS BONE SCREW 16mm 03DMLE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm WEWMKE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm WH0MKE 06-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 02AMLE 09-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 02EMLE 09-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 5D2MLE 09-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 5D5MLE 09-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 5D3MLE 09-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 5AXMLE 11-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 6E5MLE 11-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 5D1MLE 11-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 7J0MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 6E7MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 6E9MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 6E6MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 8MYMLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 971MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 97PMLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 8N1MLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 8MRMLE 14-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 9MAMLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 9MEMLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 9M9MLE 31-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 9M7MLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 8N0MLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm 9ELMLE 15-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm K2EMLE 23-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm K23MLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm K2LMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm K2PMLE 25-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm K29MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm R74MLE 28-Jul-2013 6.5 CANCELLOUS BONE SCREW 16mm JY2MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 16mm JY3MME 22-Aug-2013 6.5 CANCELLOUS BONE SCREW 16mm K2XMME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 16mm K2PMME 24-Aug-2013 6.5 CANCELLOUS BONE SCREW 16mm K2YMME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 16mm K2VMME 25-Aug-2013 6.5 CANCELLOUS BONE SCREW 16mm 3A3MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 3A7MNE 09-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 3A4MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 3A6MNE 30-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 413MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 417MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 415MNE 10-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 3A5MNE 11-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 623MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 6N5MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 6N3MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 6N4MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 786MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 78YMNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 785MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 6N2MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm 790MNE 16-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm D0EMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AVPMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AT6MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AVTMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AT5MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AVRMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm D0HMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AVWMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm AVVMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm E76MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm D0JMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm D0KMNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm E77MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm D20MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm E78MNE 21-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm EA8MNE 23-Sep-2013 6.5 CANCELLOUS BONE SCREW 16mm MER81W 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER821 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER820 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER81Y 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER823 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER7RE 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER919 16-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MER81X 19-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH6D 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH7T 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH7R 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH7V 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH54 23-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERJAA 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERJAE 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERJAD 30-Nov-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH7W 04-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH7P 04-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MERH7N 04-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET045 05-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET046 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET0XP 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET0XV 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET1EY 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET1H0 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET1H2 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET1H1 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET20Y 07-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET1H3 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET20X 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET3MD 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET3ME 10-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET3MK 11-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET49Y 12-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET043 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET044 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET0XX 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET0XT 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET0XW 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET3M8 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET4A2 14-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET8RE 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET8TD 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET8YJ 18-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METD5D 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METDE8 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METDRH 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METDEA 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METD5E 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METEAR 21-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm MET8YL 30-Dec-2013 6.5 CANCELLOUS BONE SCREW 16mm METLYT 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METM15 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METLRM 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METMRA 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METMRE 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METMRH 04-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METN5J 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm METMRD 07-Dec-2012 6.5 CANCELLOUS BONE SCREW 16mm METMRJ 07-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA09R 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA0L4 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA0RJ 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA0RK 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA0RM 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA0RL 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA1A5 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA1A8 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA1L7 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA1L8 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA3M0 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA3M1 11-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA3LY 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA4JD 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA53H 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA3M2 14-Jan-2014 6.5 CANCELLOUS BONE SCREW 16mm MHA53K 18-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: 16 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