Events

Recall of Device Recall Zimmer M/L Taper Reduced Neck Standard & Extended Offset,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68390
  • Event Risk Class
    Class 2
  • Event Number
    Z-2034-2014
  • Event Initiated Date
    2014-05-23
  • Event Date Posted
    2014-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127545
  • Notes / Alerts
    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.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    Black residue observed in the sterile pouch of the m/l taper and kinectiv stems.
  • Action
    Zimmer sent an Medical Device Recall Letter on June 4, 2014, to their Distributors. On June 9, 2014, Zimmer sent Medical Device Recall Letters to the physicians. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Locate all products from the affected lots and quarantine them immediately, if not previously done so per the May 23, 2014 Notice of Suspension of Loaner Pool. 2. Confirm the physical count of all affected product in loaner pool in your territory and complete the Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2), and email a completed copy of Attachment 2 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2). 4. Identify additional customers that may have used this product in the past 12 months by completing the spreadsheet template provided to you via email or confirm that Zimmer has identified all current customers in your territory. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Device

Device Recall Zimmer M/L Taper Reduced Neck Standard & Extended Offset,
  • Model / Serial
    Product ID: 00771100410, Lot #: 60876583, 61098988, 61158127, 61230791, 61542496, 61548105, 61702995, 61729254, 61904645, 61957233, 61963047, 61998392, 62004467, 62067479, 62078278, 62096889, 62107667, 62145541, 62153634, 62184289, 62246880, 62246881, 62253651, 62265027, 62283066, 62316369, 62343031, 62356431, 62361531, 62380986, 62390746, 62445410, 62459360, 62472165, 62495527, 62528301, 62529331, 62529334, 62529335, 62529341, 62577926, 62577929 & 62630007.  Product ID: 00771100440, Lot #: 60500974, 60597171, 60824961, 61040634, 61510553, 61601757, 61703092, 61796656, 61870553, 61880423, 61904646, 61963030, 61967702, 62101479, 62135089, 62153635, 62158616, 62176234, 62179221, 62202469, 62239214, 62253653, 62253654, 62275332, 62275333, 62302332, 62309445, 62316374, 62342712, 62405371, 62410988, 62472168, 62521896, 62554173, 62571801, 62577931, 62601210 & 62645212.  Product ID: 00771100510, Lot #: 61098989, 61158128, 61595675, 61734799, 61791458, 61870554, 61919455, 61967734, 61985992, 62023864, 62059114, 62085023, 62135094, 62135095, 62143027, 62145548, 62145549, 62145551, 62169649, 62198214, 62238349, 62243359, 62243360, 62302339, 62302341, 62342714, 62367890, 62445414, 62458976, 62459363, 62509237, 62529278, 62529353, 62529362, 62537985, 62540589 & 62554177.  Product ID: 00771100540, Lot #: 60659250, 61030264, 61085549, 61098994, 61595699, 61690452, 61749176, 61765962, 61796657, 61845539, 61865602, 61966525, 62004475, 62078283, 62096893, 62130151, 62143029, 62153639, 62158620, 62207884, 62258663, 62271060, 62275338, 62323507, 62335521, 62335522, 62361538, 62445416, 62452735, 62489955, 62503202, 62540593, 62594190 & 62615704.  Product ID: 00771100610, Lot #: 61030252, 61416334, 61523437, 61894915, 61894916, 61966499, 62085032, 62114298, 62158626, 62207887, 62219914, 62226003, 62236540, 62238352, 62243369, 62243372, 62243373, 62275343, 62289018, 62302344, 62309453, 62335525, 62356440, 62379097, 62393282, 62405381, 62409688, 62410998, 62411003, 62423064, 62423065, 62445419, 62452741, 62478872, 62478874, 62488298, 62503204, 62528348, 62528349, 62529374, 62529375, 62529377, 62529379, 62550187, 62560161, 62577945, 62615711, 62659356 & 62665753.  Product ID: 00771100640, Lot #: 60474089, 60663859, 60911091, 61158157, 61553126, 61631840, 61741531, 61851980, 61860883, 61966531, 62023869, 62059125, 62143033, 62153641, 62187415, 62198221, 62219917, 62219918, 62246894, 62246895, 62265031, 62274956, 62275347, 62343049, 62379098, 62393285, 62405385, 62445421, 62503207, 62521909, 62571810 & 62615713.  Product ID: 00771100710, Lot #: 60771280, 61273016, 61499266, 61734803, 61784581, 61812353, 61851927, 62014580, 62053391, 62078295, 62118155, 62141440, 62158635, 62201777, 62231894, 62231895, 62231898, 62243374, 62243375, 62243378, 62275356, 62282228, 62295531, 62302353, 62309465, 62335540, 62343056, 62367904, 62370016, 62381004, 62381005, 62393291, 62400759, 62405394, 62411014, 62416694, 62423075, 62452751, 62458992, 62458994, 62472190, 62488317, 62488318, 62509254, 62509255, 62528381, 62529406, 62537934, 62540614, 62547061, 62547063, 62560179, 62615729, 62645241, 62659370, 62665772, 62681694 & 62681696.  Product ID: 00771100740, Lot #: 61550135, 61631841, 61734866, 61772718, 61801919, 61972446, 62023879, 62023881, 62096907, 62135115, 62141445, 62184314, 62198237, 62207901, 62226018, 62231906, 62236548, 62253676, 62289036, 62289037, 62295537, 62309552, 62329235, 62335546, 62343068, 62381009, 62381010, 62393296, 62411019, 62416699, 62416703, 62423083, 62433065, 62433067, 62450644, 62484310, 62488330, 62496123, 62503221, 62540619, 62548499, 62586864, 62594206, 62615732, 62645247, 62645248, 62653028 & 62665780.  Product ID: 00771100910, Lot #: 61487760, 61734804, 61851922, 61919486, 61930771, 62004532, 62028813, 62085052, 62114319, 62191514, 62231919, 62243388, 62249182, 62265046, 62295542, 62295546, 62302368, 62316429, 62343075, 62350653, 62350654, 62370035, 62381023, 62405415, 62411029, 62423093, 62433074, 62438948, 62457810.62457930, 62488343, 62489427, 62509268, 62528392, 62540628, 62540631, 62547073, 62547074, 62554217, 62560009, 62560195, 62577987, 62594212, 62601242, 62608666, 62645268, 62645269 & 62667726.  Product ID: 00771100940, Lot #: 61626141, 61805446, 61865594, 62044986, 62135133, 62158651, 62179284, 62226041, 62231939, 62236554, 62246930, 62246931, 62253686, 62253687, 62271105, 62271107, 62295547, 62302374, 62316432, 62323546, 62356470, 62361568, 62379104, 62393315, 62393316, 62400772, 62411062, 62416723, 62416724, 62416726, 62484342, 62489432, 62489984, 62540634, 62554221, 62560204, 62577989, 62590723, 62594226, 62601247, 62608671, 62615739, 62622732, 62645275, 62653046 & 62667736.  Product ID: 00771101010, Lot #: 61074843, 61468181, 61755935, 61801882, 62010413, 62107715, 62114333, 62118203, 62236555, 62238371, 62243413, 62243415, 62275380, 62302387, 62316440, 62329279, 62329280, 62350671, 62350673, 62367934, 62393333, 62409705, 62433087, 62433088, 62459020, 62488365, 62496183, 62496185, 62503233, 62515365, 62515366, 62521956, 62529433, 62529437, 62537950, 62560211, 62560212, 62578001, 62578010, 62586893, 62601260, 62622743, 62630063, 62630066, 62645288, 62645289, 62645290, 62662266, 62665820 & 62665822.  Product ID: 00771101040, Lot #: 61772722, 61831167, 61851965, 61967716, 62053420, 62063891, 62114337, 62130198, 62130199, 62153683, 62179308, 62198270, 62201832, 62213783, 62246952, 62246953, 62253699, 62271119, 62289076, 62323563, 62343090, 62386116, 62393343, 62423122, 62427973, 62433096, 62433097, 62438975, 62490004, 62490005, 62496188, 62521960, 62550199, 62601265, 62608690, 62622749 & 62645296.  Product ID: 00771101110, Lot #: 61510528, 61644836, 61825649, 62014630, 62023896, 62053432, 62089285, 62107718, 62118221, 62130209, 62153694, 62153695, 62169771, 62179331, 62179334, 62231959, 62243427, 62246973, 62275394, 62275395, 62275396, 62282276, 62289085, 62302411, 62309605, 62335576, 62367948, 62381101, 62405446, 62409728, 62445474, 62452544, 62459035, 62466136, 62478927, 62537961, 2594247, 62601276, 62615767, 62630082, 62636841, 62645306, 62653080 & 62667760.  Product ID: 00771101140, Lot #: 11003867, 60697997, 61280663, 61298526, 61482862, 61601719, 61814634, 61874350, 61978850, 62096935, 62130212, 62153699, 62201846, 62219967, 62246984, 62258705, 62275399, 62289094, 62316457, 62328717, 62343103, 62370087, 62381110, 62393361, 62416752, 62427976, 62427978, 62452790, 62452791, 62472240, 62478931, 62488385, 62489453, 62489454, 62554247, 62578034, 62594255, 62608710 & 62653089.  Product ID: 00771101210, Lot #: 61178805, 61613564, 62023912, 62059189, 62085092, 62101443, 62107720, 62107722, 62118239, 62176269, 62179379, 62179381, 62207950, 62243442, 62243443, 62243445, 62243446, 62253732, 62258711, 62302435, 62309625, 62350699, 62356523, 62370093, 62381159, 62381161, 62405478, 62416759, 62427980, 62433120, 62433121, 62466147, 62472247, 62515406, 62528411, 62540672, 62547114, 62560235, 62560236, 62571906, 62578052, 62586930, 62590752, 62601294, 62608723, 62608724, 62608726, 62630099, 62645322, 62645325, 62653104 & 62665865.  Product ID: 00771101240, Lot #: 60911093, 61712776, 61831168, 61930803, 61930804, 61963039, 61966512, 62053451, 62114366, 62135178, 62135179, 62141490, 62201861, 62231982, 62247002, 62249190, 62258714, 62258715, 62271166, 62271167, 62289105, 62316472, 62350706, 62367969, 62381181, 62400811, 62416764, 62416765, 62433134, 62433135, 62459054, 62465797, 62472252, 62515416, 62515417, 62521983, 62571916, 62608731, 62630108, 62653113 & 62653114.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
  • Product Description
    Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. || The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, 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