Events

Device Recall Persona" Trabecular Metal" Tibia Plate Instruments and Modular Brackets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    74148
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1917-2016
  • 사례 시작날짜
    2016-05-11
  • 사례 출판 날짜
    2016-06-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146512
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • 원인
    Zimmer inc. is initiating a recall of specific persona" trabecular metal" tibial plate instruments and modular brackets, due to incidents of radiolucent lines and loosening in implants.
  • 조치
    Zimmer Inc. is initiating a voluntary recall of Persona" Trabecular Metal" Tibia / Tibial Plate Instruments and Modular Brackets following an increase in complaints of radiolucent lines and loosening, and earlier recall of the Persona" Trabecular Metal" Tibial Plates . All sizes and lots of the affected devices are being removed from distribution. Recall notices were issued to affected distributors, hospitals, and surgeons on 05/11/2015 via mail. Customers may contact the following with any questions: 1-877-946- 2761 between 8:00 am and 5:00pm EST. Customers are asked to do the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist Zimmer Biomet sales representative with the quarantine of any affected product. 3. Zimmer Biomet sales representative will remove the recalled product from customer facilities. 4. Complete the Certificate of Acknowledgement Form and return to: corporatequality.postmarket@zimmerbiomet.com.

Device

Device Recall Persona" Trabecular Metal" Tibia Plate Instruments and Modular Brackets
  • 모델명 / 제조번호(시리얼번호)
    Part Number, Lot Number, Date of Manufacture:  42509909210, 63138589, 07/28/2015; 42509909210, 63097616, 06/10/2015; 00590708181, 56595825, 04/20/2015; 00590708185, 56610423, 03/12/2015; 00590708176, 56595826, 03/04/2015; 00590708179, 56595827, 03/04/2015; 00590708180, 56595828, 03/04/2015; 00590708181, 56595824, 03/02/2015; 00590708178, 56595692, 02/17/2015; 00590708176, 56595691, 02/16/2015; 00590708177, 56595801, 02/16/2015; 00590708180, 56595694, 02/04/2015; 00590708179, 56595693, 01/29/2015; 00590708181, 56595642, 01/20/2015; 00590708177, 56595625, 01/06/2015; 42539807902, 62906456, 12/14/2014; 00590708178, 56595569, 12/12/2014; 42539808802, 62885379, 11/22/2014; 42539807102, 62885377, 11/21/2014; 42539806702, 62885376, 11/20/2014; 42539806701, 62885375, 11/18/2014; 42539808801, 62863647, 10/29/2014; 42539802000, 62854350, 10/16/2014; 42539808802, 62849167, 10/14/2014; 42539806702, 62849168, 10/13/2014; 42539807502, 62839311, 10/08/2014; 42539807101, 62833614, 10/07/2014; 42539802000, 62844358, 10/07/2014; 42539808301, 62839310, 10/04/2014; 42539806401, 62833616, 10/03/2014; 42539807101, 62839312, 10/03/2014; 42539800500, 62844377, 09/30/2014; 42539802000, 62827692, 09/29/2014; 42539807901, 62831188, 09/25/2014; 42539808301, 62833610, 09/25/2014; 00590708176, 56595440, 09/25/2014; 42539806401, 62837612, 09/24/2014; 42539807502, 62833612, 09/24/2014; 00590708179, 56595441, 09/24/2014; 00590708180, 56595442, 09/24/2014; 42539807501, 62831191, 09/22/2014; 00590708181, 56595443, 09/18/2014; 42539807501, 62827408, 09/15/2014; 42539807901, 62827407, 09/15/2014; 42509909210, 62817496, 09/08/2014; 42539806402, 62817469, 09/03/2014; 42539808302, 62817467, 09/03/2014; 42539807902, 62817468, 09/02/2014; 42539806701, 62813822, 08/24/2014; 00590708177, 56595435, 08/05/2014; 42539802000, 62769875, 08/03/2014; 42539800500, 62779559, 07/30/2014; 42539800100, 62779557, 07/29/2014; 42539800700, 62769874, 07/28/2014; 42539800100, 62769871, 07/27/2014; 42539800500, 62769872, 07/27/2014; 42509909210, 62782990, 07/24/2014; 00590708176, 56595308, 07/17/2014; 42539807101, 62741938, 07/07/2014; 42539808802, 62736082, 06/26/2014; 42539807501, 62736060, 06/25/2014; 42539808801, 62736081, 06/25/2014; 42539807502, 62732180, 06/19/2014; 42539806401, 62724757, 06/14/2014; 42539806702, 62736062, 06/14/2014; 42539807501, 62696888, 05/14/2014; 42539807901, 62702760, 05/05/2014; 42539808301, 62702762, 05/02/2014; 42539807102, 62665087, 04/09/2014; 42509909210, 62658516, 04/03/2014; 42539807902, 62677171, 04/02/2014; 42539806701, 62677173, 04/01/2014; 42539806402, 62677172, 04/01/2014; 42539808302, 62677174, 04/01/2014; 42539800100, 62550569, 12/14/2013; 42539800700, 62550582, 12/13/2013; 42509909210, 62563823, 12/09/2013; 42539800500, 62550573, 11/23/2013; 42539800100, 62550565, 11/18/2013; 42539800700, 62550578, 11/18/2013; 42539802000, 62550588, 11/13/2013; 42539800500, 62519720, 11/11/2013; 42539802000, 62485450, 09/03/2013; 42539807101, 62474901, 08/22/2013; 42539808801, 62469464, 08/20/2013; 42539808802, 62469457, 08/20/2013; 42509909210, 62468258, 08/20/2013; 00590708186, 56524701, 08/20/2013; 42539807501, 62469447, 08/16/2013; 00590708186, 56524691, 08/16/2013; 42539807901, 62469448, 08/15/2013; 42539807502, 62469449, 08/15/2013; 00590708185, 56529311, 08/14/2013; 42509909210, 62460135, 08/02/2013; 42539806702, 62449207, 08/01/2013; 42539806401, 62424809, 07/26/2013; 42539807502, 62424810, 07/25/2013; 42539808802, 62429189, 07/25/2013; 42539807501, 62429187, 07/24/2013; 00590708185, 56570277, 07/17/2013; 42509909210, 62442315, 07/16/2013; 00590708186, 56524662, 07/16/2013; 00590708185, 56570276, 07/12/2013; 42539807102, 62420235, 07/08/2013; 42539800100, 62434639, 07/08/2013; 42539800500, 62434641, 07/08/2013; 42539800700, 62434642, 07/08/2013; 42509909210, 62429474, 06/28/2013; 42539807901, 62419053, 06/27/2013; 42539807101, 62420230, 06/26/2013; 42539807101, 62391499, 06/25/2013; 42539807901, 62391505, 06/25/2013; 00590708186, 56524634, 06/21/2013; 42539807902, 62386403, 06/20/2013; 42539808801, 62377922, 06/17/2013; 42539806402, 62377911, 06/17/2013; 42539808301, 62377914, 06/12/2013; 42539808302, 62377918, 06/12/2013; 42539806401, 62385935, 06/11/2013; 42539806701, 62386402, 06/11/2013; 00590708179, 56528980, 06/11/2013; 42539802000, 62364964, 06/07/2013; 42509909210, 62412194, 06/07/2013; 42539800700, 62357622, 06/03/2013; 42539807101, 62357870, 05/24/2013; 42539807901, 62366122, 05/24/2013; 42539806702, 62366119, 05/24/2013; 42509909210, 62399872, 05/24/2013; 42539800500, 62315770, 05/18/2013; 42539800100, 62386789, 05/16/2013; 42539800500, 62315769, 05/16/2013; 42539800100, 62301872, 05/15/2013; 00590708178, 56528979, 05/11/2013; 42539807902, 62366123, 05/09/2013; 42509909210, 62383744, 05/07/2013; 42539807501, 62301873, 05/06/2013; 42539807102, 62315772, 05/06/2013; 42539807502, 62301874, 05/06/2013; 42539807902, 62301875, 05/06/2013; 00590708176, 56528977, 05/02/2013; 00590708180, 56528981, 05/01/2013; 00590708181, 56528982, 05/01/2013; 00590708177, 56528978, 04/30/2013; 42539808802, 62374294, 04/25/2013; 42509909210, 62369694, 04/22/2013; 42539808802, 62357874, 04/17/2013; 42539808802, 62357873, 04/17/2013; 42539808801, 62357872, 04/16/2013; 42539808801, 62357871, 04/15/2013; 42509909210, 62357131, 04/04/2013; 42539808302, 62290686, 03/29/2013; 42509909210, 62345129, 03/22/2013; 00590708185, 56529104, 03/22/2013; 00590708179, 56519351, 03/20/2013; 00590708186, 56524431, 03/12/2013; 00590708186, 56524539, 03/11/2013; 00590708178, 56519339, 03/09/2013; 42509909210, 62331503, 03/07/2013; 00590708186, 56524430, 03/05/2013; 00590708177, 56519352, 02/26/2013; 00590708176, 56519335, 02/19/2013; 00590708178, 56519338, 02/19/2013; 00590708180, 56519348, 02/18/2013; 42539807501, 62274305, 02/14/2013; 42539806402, 62276254, 02/14/2013; 00590708179, 56519350, 02/13/2013; 00590708181, 56519337, 02/13/2013; 42539807502, 62274296, 02/05/2013; 42539807902, 62274276, 02/05/2013; 42539802000, 62274308, 02/05/2013; 42539806701, 62292435, 01/29/2013; 42539808301, 62289365, 01/24/2013; 42539807901, 62281193, 01/21/2013; 42539807101, 62256180, 01/15/2013; 42539806702, 62256179, 01/15/2013; 42539808302, 62276680, 01/15/2013; 42539800100, 62264917, 01/15/2013; 42539800500, 62264918, 01/15/2013; 42539800700, 62264919, 01/15/2013; 42539807102, 62254389, 01/14/2013; 42539800700, 62264920, 01/14/2013; 42539806402, 62248613, 12/05/2012; 42539806401, 62248612, 12/03/2012; 42539806701, 62248614, 12/03/2012; 00590708179, 56519203, 12/03/2012; 42539800100, 62244002, 11/26/2012; 42539800500, 62244003, 11/26/2012; 42539800700, 62244004, 11/26/2012; 00590708176, 56519244, 11/26/2012; 00590708178, 56519210, 11/26/2012; 00590708180, 56519219, 11/26/2012; 00590708177, 56519247, 11/24/2012; 00590708179, 56519204, 11/24/2012; 00590708180, 56519217, 11/24/2012; 00590708180, 56519218, 11/24/2012; 00590708181, 56519207, 11/24/2012; 00590708178, 56519209, 11/20/2012; 42539806701, 62237938, 11/19/2012; 42539808301, 62239035, 11/19/2012; 42539806402, 62237937, 11/19/2012; 42539808302, 62239029, 11/19/2012; 42539807101, 62233958, 11/16/2012; 42539807902, 62237932, 11/16/2012; 00590708176, 56519243, 11/16/2012; 00590708181, 56519206, 11/16/2012; 42539807501, 62237929, 11/15/2012; 42539807901, 62233959, 11/15/2012; 42539808301, 62237935, 11/15/2012; 42539807102, 62237962, 11/15/2012; 42539807502, 62237886, 11/15/2012; 42539808302, 62237936, 11/15/2012; 42539802000, 62233960, 11/15/2012; 00590708177, 56519246, 11/15/2012; 42539806401, 62226724, 11/14/2012; 42539806701, 62224797, 11/14/2012; 42539806402, 62224795, 11/14/2012; 00590708176, 56519242, 11/07/2012; 00590708178, 56519208, 11/07/2012; 00590708179, 56519202, 11/07/2012; 00590708181, 56519205, 11/07/2012; 00590708177, 56519245, 11/06/2012; 42539806401, 62214944, 10/22/2012; 42539806702, 62214945, 10/18/2012;
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI; Foreign: Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates.
  • 제품 설명
    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA