Events

Rappel de Device Recall Persona" Trabecular Metal" Tibia Plate Instruments and Modular Brackets

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer Biomet, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74148
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1917-2016
  • Date de mise en oeuvre de l'événement
    2016-05-11
  • Date de publication de l'événement
    2016-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146512
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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;
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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