Events

Device Recall Ossur Total Knee 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ossur North America 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
    35132
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1199-06
  • 사례 시작날짜
    2006-03-29
  • 사례 출판 날짜
    2006-07-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-08-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45390
  • 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
    Joint, Knee, External Limb Component - Product Code ISY
  • 원인
    The company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
  • 조치
    On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.

Device

Device Recall Ossur Total Knee
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 38198 ¿ 40858 including the following repaired units outside the stated range. 18989,19232, 27029, 27804, 28629, 28923, 30538, 31033, 31104, 31108, 31110, 31111, 31113, 32040, 32229, 32293, 32352, 32528, 32556, 32704, 32712, 32849, 33016, 33035, 33038, 33435, 33626, 33644, 33770, 33963, 34025, 34032, 34131, 34205, 34257, 34331, 34362, 34448, 34544, 34562, 34578, 34631, 34753, 34756, 34783, 34870, 34926, 34994, 35125, 35257, 35328, 35412, 35755, 35810, 35819, 35845, 35969, 35981, 36157, 36209, 36391, 36636, 36665, 36733, 36871, 36902, 36955, 36960, 37098, 37114, 37128, 37147, 37172, 37243, 37255, 37291, 37310, 37554, 37625, 37717, 37788, 37910, 37987, 38047, 38197.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • 제품 설명
    Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • 제조사 주소
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA