Devices

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

  • Model / Serial
    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;
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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.
  • 1 Event

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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