Events

Device Recall Synthes Resorbable Fixation Systems Resorbable Taps and Screws 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes (USA) 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
    35109
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0792-06
  • 사례 시작날짜
    2006-03-30
  • 사례 출판 날짜
    2006-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-09-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45332
  • 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
    Plate, Bone - Product Code JEY
  • 원인
    Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
  • 조치
    Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06.

Device

Device Recall Synthes Resorbable Fixation Systems Resorbable Taps and Screws
  • 모델명 / 제조번호(시리얼번호)
    Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1387942, 09/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751, 07/2009; 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122, 07/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368, 10/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323, 02/2010; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135, 07/2009; 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578, 8/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219, 09/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401, 07/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile,  805.603.20S, 1372402, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984, 02/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 1384599, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 1392088, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 2162401, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 2169299, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1370041, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1377502, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1385780, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1393234, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.20S, 1383881, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288, 11/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842, 02/2010; 1.5MM rapid resorbable cortex screw 5MM-sterile,  805.605.04S, 1384604, 08/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091, 09/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289, 11/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134, 07/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551, 01/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile,  805.606.02S, 1393239, 09/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849, 02/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288, 10/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641, 07/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291, 11/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile,  805.608.02S, 2171103, 12/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552, 01/2010; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009; 1.5MM rapid resorbable tack 4MM-sterile,  805.614.10S, 2165696, 11/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile,  806.006.02S, 2167290, 11/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile,  806.006.10S, 1374136, 07/2009; 2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093, 09/2009; 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, AND WV.
  • 제품 설명
    Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
  • Manufacturer
    Synthes (USA)

Manufacturer

Synthes (USA)
  • 제조사 주소
    Synthes (USA), 1302 Wrights Lane East, West Chester PA 19380
  • Source
    USFDA