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  Class 2 Device Recall smith&hephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL see related information
Date Initiated by Firm April 22, 2020
Create Date June 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-2331-2020
Recall Event ID 85637
510(K)Number K070756  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
Product smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71331842
48MM 71331848
50MM 71331850
52MM 71331852
54MM 71331854
56MM 71331856
58MM 71331858
60MM 71331860
Orthopedic implant component.

Code Information 71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572   71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829   71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A    71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A  71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM08695, 18MM08697, 18MM08724, 19AM17823, 19AM17833, 19AM17837, 19AM17845, 18MM08650A, 18MM08663A, 19AM17845A, 19AM17833A, 19AM17837A  71331856, Lot Numbers: 18JM15947, 18MM12475, 18JM15950, 18KM04251, 18HM19101, 18JM15940, 18KM04254, 18HM19123, 18KM15773, 18JM15949, 18JM15949A, 18LM18546, 18HM19116, 18HM19117, 18JM15941, 18KM04226, 18KM04250, 18KM04252, 18KM04253, 18KM13646, 18KM17025, 18KM17026, 18KM17029, 18KM17031, 18KM17032, 18LM18544, 18LM18550, 18MM12424, 18MM12426, 18MM12428, 18MM15587, 18MM15611, 18LM05390, 18KM17031A, 18LM18550A    71331858, Lot Numbers: 19AM03504, 19AM03511   71331860, Lot Numbers: 18JM10154, 18JM10154A
Recalling Firm/
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
Manufacturer Reason
for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
FDA Determined
Cause 2
Process control
Action The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.
Quantity in Commerce 1267 devices
Distribution Worldwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBL and Original Applicant = SMITH & NEPHEW, INC.