Device Recall Synthes Inserter for Titanium Elastic Nails 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes, 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
    70580
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1260-2015
  • 사례 시작날짜
    2015-02-03
  • 사례 출판 날짜
    2015-03-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    The inserter has the potential for mechanical failures such as breakage of the main shaft of the inserter for the ten, malfunction of the chuck of the inserter for the ten in the form of the chuck getting stuck/jammed, breakage of the cross bar of the inserter for the ten.
  • 조치
    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 3, 2015, to all affected customers to alert them about the recall and explain the benefits and risks associated with removing this device from the market. It stated that the immediate removal of the product would prevent the performance of emergency surgery, thus DePuy Synthes is not requiring an immediate removal of affected product(s). DePuy Synthes is in the process of developing the replacement & recovery plan for indicated devices. Due to their current but temporary lack of replacement inventory, Synthes proposed to remove and replace the device in increments to prevent any adverse impact on the availability of the device for use on patients in trauma-related surgery events. DePuy Synthes will contact customers as replacements become available. Customers were advised to complete the Verification Section by checking the appropriate box indicating affected product has been located. Also,indicate the number of devices found. If your facility chooses to return the product(s) at this time, please take the following additional steps:Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, include a copy of Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.Send the completed Verification Section to the following fax or email address: Fax: (866) 782-7287 or Scan/email: Synthes5095@stericycle.com Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 810-719-5000.

Device

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 359.219,  Sold As Lot Numbers: 4321659 4340451 4466686 4470900 5496455 5700078 5718485 5718486 5718487 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483 3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835 7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491 7810649 7845943 7874224 7896075 7979727 4796463 4826021 4911859 4911860 4969014 4971314 5066417 5042001 5066418 5090226 5090224 5106335 5123586 5162204 5123587 5162205 5162206 5162760 5181760 5181761 5227459 5236654 5258103 5420946 5422955 5455364 5455365 5507788 5525235 5485078 5492810 5545372 5555604 5569028 5611445 5611446 5611447 5641430 5670475 5641429 5657075 5657073 5670474 5700077 5700079 8114862 8214803 8326267 8424513 8476286 8541845 8608192 8608193 8768253 8973607 9275702 4389269 4537554 4594280 4594281 4825384;  (Manufacturing Lot Numbers: 1095607 1095607 1121876 1121876 1641700 1806500 1811056 1811059 1813900 1904339 3005674 3005675 3009312 3020674 3025607 3051190 3054608 3065013 3069566 3084637 3098634 3121438 3232931 3242304 3262712 3301017 3325276 3382583 3410330 3430483 3493588 3504996 3524633 3619119 3626055 3659645 3706611 3797835 7505411 7565990 7601112 7619995 7670741 7675623 7727696 7774491 7810649 7845943 7874224 7896075 7979727 8000136 8002518 8002635 8002635 8004538 8004538 8005179 8006103 8006214 8006214 8006578 8006578 8007139 8007139 8007472 8007472 8008046 8008046 8008046 8008261 8009205 8009363 8009859 8012109 8012353 8012925 8013244 8014078 8014078 8014645 8014645 8015605 8015831 8016063 8016128 8016128 8016128 8016423 8016423 8016759 8017447 8017590 8017862 8017872 8018319 8114862 8214803 8326267 8424513 8476286 8541845 8608192 8608193 8768253 8973607 9275702 A8LA901 A8MA648 A8MB744 A8NA025 A8NA430)
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. || This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
  • Source
    USFDA