Class 2 Device Recall TANDEM Bipolar Hip System

• Date Initiated by Firm: August 29, 2016
• Create Date: November 03, 2016
• Recall Status: Terminated on August 16, 2019
• Recall Number: Z-0350-2017
• Recall Event ID: 75283
• 510(K)Number: K023743
• Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: Joe Metzger; 978-749-1330
• Manufacturer Reason for Recall: Some Bipolar shells were manufactured with an out of specification retainer groove.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 2352 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWY and Original Applicant = SMITH & NEPHEW, INC.