Events

Device Recall GLOBAL APG 2.5mm Guide Pin 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 DePuy Orthopaedics, Inc. 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
    67691
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1437-2014
  • 사례 시작날짜
    2014-03-28
  • 사례 출판 날짜
    2014-04-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126076
  • 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
    Template - Product Code HWT
  • 원인
    Urgent device correction notifications are being sent to usa distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.
  • 조치
    Beginning 3/28/12014 DePuy United States Distributors and DePuy affiliate contacts for Canada and International will be notified via email. The US Distributors will be responsible for adhering to the directions outlined in the field communication, including identifying the Surgeon users and notifying them either by mail or in person with the Surgeon Letter and providing access to revised surgical techniques. The notice emphasized technical points regarding the use of the GLOBAL APG+ 2.5mm Breakaway Guide Pin (singleuse shoulder instrument) that have been added to the surgical techniques. Risks were explained and surgical techniques revised were identified and available through the distributor. Distributors were asked to identify surgeons using the device, filling out the response form. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 18885542482 (MF; 8 a.m.  5 p.m. EDT). For product related questions, please contact your local DePuy Orthopaedics, Inc., Sales Consultant." For questions about recall information provided: Kim Earle, Recall Coordinator, 5743714917 (MF; 8 a.m.  5 p.m. EDT)

Device

Device Recall GLOBAL APG 2.5mm Guide Pin
  • 모델명 / 제조번호(시리얼번호)
    Label Lot Laser Lot D38FX4 PG0809 D5AA34 PG1009 D5AA44 PG1109 E1WC14 PG0710 E1WC24 PG0710 E1WC34 PG0810 E1WC44 PG0810 E1WCY4 PG0710 E24A44 PG0810 E24A54 PG0810 E28CB4 PG0810 E29G14 PG1210 E2FCW4 PG0810 E2FCX4 PG0810 E2FCY4 PG0810 E2VB24 PG0910 E2VB34 PG0810 E2VB44 PG0810 E2VB54 PG0910 E2VB64 PG0910 E2VB74 PG1010 E41E44 PG1010 E41E54 PG1010 E4DA54 PG0910 E4FDM4 PG0910 E4FDN4 PG1110 E4FDP4 PG0910 E4FKJ4 PG1010 E4FKK4 PG1110 E4FKL4 PG1010 E4XFD4 PG0910 E4XFE4 PG0910 E4XGL4 PG1010 E4XGM4 PG1010 E4XGN4 PG1010 E4XGR4 PG1010 E4XGS4 PG1010 E4XGT4 PG1010 E54BL4 PG1110 E54BP4 PG1110 E56JF4 PG1210 E56JG4 PG1210 E57F14 PG1210 E57F24 PG1210 E57F34 PG1210 E57F44 PG1110 E57FV4 PG1110 E57FW4 PG1110 E57FY4 PG1210 E5CCG4 PG1010 E5CCH4 PG1010 E5CCJ4 PG1010 E5CCK4 PG1010 E5NJV4 PG1110 E5PBJ4 PG1210 E5PEA4 PG1110 E6CHE4 PG1110 E6DDE4 PG1210 E6DDF4 PG1210 E75AK4 PG1210 E75AL4 PG1210 E87GG4 PG1210 E87GH4 PG0111 E87GJ4 PG0111 E87GK4 PG1210 E87GL4 PG0111 E87GM4 PG0111 E87GN4 PG0111 E87HW4 PG0111 EG8FF4 PG0410 EG8FG4 PG0410 EL6PY4 PG0510 EP4F84 PG0510 EP4GF4 PG0510 ET3BY4 PG0610 ET3JD4 PG0510 ET3JE4 PG0610 ET3JF4 PG0510 EW1D64 PG0710 EW1D74 PG0610 EW1D84 PG0610 EW1D94 PG0610 EW1EA4 PG0710 EW1EB4 PG0610 FA3D54 PG0111 FA3D64 PG0111 FA3D74 PG0211 FA5LE4 PG1210 FB1FP4 PG0211 FB1GY4 PG0211 FC2RC4 PG0211 FE8AP4 PG0211 FF8HC4 PG0211 FL5D44 PG0411 FL5D54 PG0411 FL5D74 PG0411 FL5D84 PG0411 FL6BG4 PG0311 FP3C14 PG0411 PG000035 PG0611 PG000036 PG0511 PG000037 PG0511 PG000038 PG0511 PG000039 PG0411 PG000040 PG0411 PG000042 PG0411 PG000043 PG0411 PG000116 PG0511 PG000117 PG0611 PG000316 PG0611 PG000317 PG0511 PG000360 PG0611 PG000361 PG0611 PG000400 PG0511 PG000401 PG0611 PG000427 PG0611 PG000428 PG0611 PG000468 PG0711 PG000469 PG0711 PG000470 PG0711 PG000471 PG0611 PG000472 PG0611 PG000473 PG0611 PG000628 PG0711 PG001042 PG0411 PG217084 PG217084 PG217085 PG217085 PG217574 PG217574 PG217575 PG217575 PG217576 PG217576 PG217577 PG217577 PG217578 PG217578 PG218621 PG218621 PG218622 PG218622 PG218623 PG218623 PG218624 PG218624 PG218625 PG218625 PG218626 PG218626 PG218627 PG218627 PG218628 PG218628 PG218629 PG218629 PG218630 PG218630 PG218631 PG218631 PG218632 PG218632 PG218633 PG218633 PG218634 PG218634 PG218635 PG218635 PG218636 PG218636 PG218637 PG218637 PG218638 PG218638 PG218640 PG218640 PG222517 PG222517 PG222518 PG222518 PG222519 PG222519 PG222520 PG222520 PG222521 PG222521 PG222522 PG222522 PG222523 PG222523 PG222524 PG222524 PG222525 PG222525 PG222526 PG222526 PG222527 PG222527 PG222528 PG222528 PG222529 PG222529 PG222530 PG222530 PG222531 PG222531 PG222532 PG222532 PG222533 PG222533 PG222534 PG222534 PG223040 PG223040 PG223041 PG223041 PG223042 PG223042 PG223043 PG223043 PG223044 PG223044 PG223045 PG223045 PG223046 PG223046 PG223047 PG223047 PG223048 PG223048 PG223049 PG223049 PG223050 PG223050 PG223051 PG223051 PG223052 PG223052 PG223053 PG223053 PG223054 PG223054 PG223055 PG223055 PG223056 PG223056 PG223057 PG223057 PG223058 PG223058 PG223059 PG223059 PG223060 PG223060 PG225386 PG225386 PG225387 PG225387 PG225388 PG225388 PG225389 PG225389 PG225390 PG225390 PG225391 PG225391 PG225581 PG225581 PG225582 PG225582 PG227538 PG227538 PG227539 PG227539 PG227540 PG227540 PG227541 PG227541 PG227542 PG227542 PG227543 PG227543 PG227544 PG227544 PG227545 PG227545 PG229836 PG229836 PG229837 PG229837 PG229838 PG229838 PG229839 PG229839 PG229840 PG229840 PG229841 PG229841 PG229842 PG229842 PG229843 PG229843 PG229844 PG229844 PG229845 PG229845 PG229846 PG229846 PG229847 PG229847 PG229848 PG229848 PG229849 PG229849 PG229850 PG229850 PG230679 PG230679 PG230680 PG230680 PG230681 PG230681 PG230682 PG230682 PG230683 PG230683 PG230684 PG230684 PG230685 PG230685 PG230686 PG230686 PG230687 PG230687 PG230688 PG230688 PG230689 PG230689 PG230690 PG230690 PG230691 PG230691 PG230692 PG230692 PG230693 PG230693 PG230694 PG230694 PG232133 PG232133 PG232134 PG232134 PG232135 PG232135 PG232136 PG232136 PG232137 PG232137 PG232138 PG232138 PG232139 PG232139 PG232140 PG232140 PG232141 PG232141 PG232142 PG232142 PG232143 PG232143 PG233118 PG233118 PG233119 PG233119 PG233120 PG233120 PG233121 PG233121 PG233122 PG233122 PG233123 PG233123 PG233124 PG233124 PG233125 PG233125 PG233126 PG233126 PG233127 PG233127 PG233128 PG233128 PG233129 PG233129 PG233130 PG233130 PG233131 PG233131 PG236014 PG236014 PG236015 PG236015 PG236016 PG236016 PG236017 PG236017 PG236018 PG236018 PG236019 PG236019 PG236020 PG236020 PG236021 PG236021 PG236721 PG236721 PG236722 PG236722 PG236723 PG236723 PG236724 PG236724 PG236725 PG236725 PG236726 PG236726 PG236727 PG236727 PG236728 PG236728 PG236729 PG236729 PG236730 PG236730 PG236731 PG236731 PG236732 PG236732 PG236733 PG236733
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution including Canada
  • 제품 설명
    GLOBAL¿ Anchor Peg Glenoid Plus || (APG+) 2.5MM Breakaway Guide Pin || Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson || Product Usage: Usage: || The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA