Events

Rappel de Device Recall TANDEM Bipolar Hip System

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 Smith & Nephew, 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
    75283
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0350-2017
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149948
  • 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, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
  • Cause
    Some bipolar shells were manufactured with an out of specification retainer groove.
  • Action
    The firm initiated their recall by FedEx and Email on 08/29/2016 to hospitals and distributors and requested the return of any in stock product. International consignees were notified by Email on 08/29/2016. Additionally, the firm notified the US physician of the issue by overnight letter on 09/08/2016.

Device

Device Recall TANDEM Bipolar Hip System
  • Modèle / numéro de série
    REF NUMBER 71322040 Serial Numbers: 14AM13511, 14AM13511A  REF NUMBER 71322041 Serial Numbers: 14AM21654  REF NUMBER 71322042 Serial Numbers: 13LM06353, 13MM17938, 13MM17940, 14AM01852, 14AM04660, 14AM04662, 13LM06354, 13MM17939   REF NUMBER 71322043 Serial Numbers: 13KM21801, 13LM09191, 13MM09504, 14AM01946, 14AM04663, 14BM15318, 13LM06356, 13LM09204, 13MM09507, 14AM02029, 14AM21664, 14BM15318A, 13LM06356A, 13MM02843, 14AM01855, 14AM02046, 14BM01137, 14BM19345  REF NUMBER 71322044 Serial Numbers:  13KM21825, 13LM09225, 13MM09510, 14AM02112, 14AM04670, 14BM08940A, 13KM24083, 13LM09236, 13MM09517, 14AM02118, 14AM13546, 13KM24083A, 13LM09236A, 13MM09517A, 14AM02120, 14BM01133, 13KM24084, 13MM02853, 13MM09517B, 14AM02120A, 14BM01133A, 13LM06357, 13MM02857, 13MM14125, 14AM04667, 14BM08938, 13LM06361, 13MM02857A, 13MM14135, 14AM04668, 14BM08940   REF NUMBER 71322045 Serial Numbers:  13KM17382, 13KM24087, 13MM02862A, 13MM17942, 14AM04672, 14BM08950, 13KM21826, 13LM00819, 13MM09520, 13MM17943, 14AM13549, 14BM08958,  13KM22753, 13LM09243, 13MM09520A, 13MM17943A, 14AM21666, 14BM15339, 13KM22755, 13LM09247, 13MM09523, 14AM02117, 14AM21669, 13KM24086,  13MM02862, 13MM17941, 14AM02117A, 14BM06955    REF NUMBER 71322046 Serial Numbers:  13KM17387, 13LM09274, 13LM11684, 13MM09524A, 14AM04682, 14BM15355, 13KM22756, 13LM09275, 13MM02888A, 13MM09526, 14AM13552, 14BM15358, 13KM22756A, 13LM09275A, 13MM02892, 13MM09527, 14AM21677, 14BM16787,  13KM24089, 13LM09278, 13MM02893, 13MM09991, 14AM21681, 14BM19253, 13LM00818, 13LM09281, 13MM02893A, 14AM02121, 14BM06952, 13LM00818A, 13LM11683, 13MM02897, 14AM02121A, 14BM12173, 13LM09258, 13LM11683A, 13MM09524, 14AM02124, 14BM12174   REF NUMBER 71322047 Serial Numbers:  13LM00809, 13LM00817B, 13LM11695, 13MM02901, 14AM21693, 14BM16794A, 13LM00809A, 13LM09285A, 13LM11700, 13MM02901B, 14BM12175, 14BM16795, 13LM00810, 13LM09289, 13LM14993, 13MM09528, 14BM12176, 14BM16795A, 13LM00816, 13LM09289A, 13LM15004, 13MM09529, 14BM16791, 13LM00817A,  13LM11689, 13MM02900, 14AM02127, 14BM16794   REF NUMBER 71322048 Serial Numbers:  13LM01881, 13LM01886, 13LM11730, 13MM02905, 14AM13555, 14BM08977, 13LM01882, 13LM11707, 13LM11730A, 13MM09994, 14AM16949, 14BM12177, 13LM01883, 13LM11707A, 13LM11731, 13MM17944, 14AM16951, 13LM01883A, 13LM11709, 13LM14017, 13MM17947, 14BM08976   REF NUMBER 71322049 Serial Numbers:  13LM01887, 13LM01889, 13LM11734, 13MM02906, 13MM13869A, 13MM14122A, 13LM01888, 13LM01890, 13LM14022, 13MM13868, 13MM14119, 14BM12178, 13LM01888A, 13LM11732, 13LM14023, 13MM13869, 13MM14122, 14BM12178A    REF NUMBER 71322050 Serial Numbers:  13LM11735, 13LM12855, 13LM15017, 13MM13870, 13MM17994, 13LM12820, 13LM12957, 13LM15751, 13MM13871, 13MM17995, 13LM12852, 13LM12960, 13LM15751A, 13MM13871A, 14BM01122  REF NUMBER 71322051 Serial Numbers:  13LM12961, 13LM12962A, 13LM14032A, 13LM14035, 13MM13872, 14BM16796, 13LM12961A, 13LM14025, 13LM14033, 13LM14037, 13MM13873, 14BM16796A, 13LM12962, 13LM14032, 13LM14034A, 13LM16186, 13MM17997   REF NUMBER 71322052 Serial Numbers:  13LM16191, 14AM02691, 14AM02694, 14AM04689, 14BM12179A, 14BM12182A, 13LM16192, 14AM02691A, 14AM04683, 14AM21695, 14BM12179B, 14BM12182B,  13LM16193, 14AM02692, 14AM04687, 14AM21695A, 14BM12181, 13LM16193A, 14AM02693, 14AM04688, 14BM12179, 14BM12182   REF NUMBER 71322053 Serial Numbers:  13LM16195, 14AM02695, 14AM02697, 14AM16934, 14AM21696, 14BM12183, 13LM16197,  14AM02696, 14AM06639, 14AM16935, 14AM21696A, 14BM12184   REF NUMBER 71322054 Serial Numbers:  13KM22757, 13LM16204, 14AM02699, 14AM02701B, 14AM16936, 14BM12186, 13KM22758, 13LM16204A, 14AM02700, 14AM02702, 14AM16937, 13LM16203, 13MM03205, 14AM02701, 14AM02702A, 14AM16937A, 13LM16203A, 14AM02698,  14AM02701A, 14AM02703, 14BM12185   REF NUMBER 71322055 Serial Numbers:  13LM16205, 14AM02710A, 14AM16940, 14BM01110A, 14BM12187, 14AM02710, 14AM16938, 14BM01110, 14BM01110B   REF NUMBER 71322057 Serial Numbers:  14AM16597, 14AM16597A
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates
  • Description du dispositif
    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, || REF NUMBERS: || 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
    Smith & Nephew plc
  • Source
    USFDA