Events

Recall of Device Recall TANDEM Bipolar Hip System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, 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
    75283
  • Event Risk Class
    Class 2
  • Event Number
    Z-0350-2017
  • Event Initiated Date
    2016-08-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149948
  • 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, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA