Z-1917-2016 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-1917-2016 was initiated by Zimmer Biomet, Inc. on May 11, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jun 2, 2017). Affected quantity: 10,256.

Recall Details

Product Type
Devices
Report Date
Jun 15, 2016
Initiation Date
May 11, 2016
Termination Date
Jun 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,256

Product Description

Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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; 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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;

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1917-2016
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.