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U.S. Department of Health and Human Services

Class 2 Device Recall smith&hephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL

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  Class 2 Device Recall smith&hephew R3 ZERO HOLE HA COATED 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-2332-2020
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 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes:
Size REF/product number
42MM 71332242
46MM 71332246
48MM 71332248
50MM 71332250
52MM 71332252
54MM 71332254
56MM 71332256
58MM 71332258
60MM 71332260
62MM 71332262
64MM 71332264
Orthopedic implant component.
Code Information 71332242, Lot Numbers: 18HM20693, 18HM20693A  71332246, Lot Numbers: 19EM17729, 19EM17730, 19EM17730A  71332248, Lot Numbers: 18MM01856, 19BM08386, 19DM17884, 19DM17885, 19DM17890, 19EM11946, 19EM11947, 19DM17881, 18GM04752, 18GM04753, 18HM00807  71332250, Lot Numbers: 18JM05436, 18JM05435, 18JM05436, 19BM17964, 19DM06430, 19DM06500, 19EM03960, 18FM17594, 18GM01199, 18EM13916, 18EM13934, 18JM12796, 18JM12800, 19BM17961, 19CM15771, 19EM03956, 19EM03970, 18EM13916A, 18EM13916B, 18FM00218  71332252, Lot Numbers: 18FM02450, 18FM11167, 18GM09577, 18HM15279, 18HM15304, 18HM23477, 18HM23481, 18JM12802, 18JM12811, 18KM03172, 18LM10404, 18LM10407, 19DM21921, 19DM21927, 19EM09563, 19EM09574, 18FM01063, 18GM01228, 18GM04749, 18GM06567, 18GM17030, 18EM06114, 18EM06116, 18FM01038, 18FM00235, 18MM02061, 18MM05779, 19DM21920, 19DM21922, 19DM21925, 19DM21920A  71332254, Lot Numbers: 18FM02451, 18GM16977, 18HM15323, 18JM08634, 18JM08635, 18JM08636, 18LM10411, 18LM10411A, 18LM10411B, 18LM10414, 18MM10067, 18MM10067A, 18MM10070, 18MM10127, 18MM10127A, 18MM10144, 19BM06673, 19BM16061, 19BM16064, 19BM16066, 19BM16067, 19BM16068, 19CM04082, 19CM04084, 19CM08204, 19CM08206, 19CM08207, 19CM08209, 19CM08211, 19CM19656, 19CM19658, 19CM19658A, 19CM19703, 19CM19765, 19CM19769, 19CM19838, 19CM19838A, 19CM19839, 19CM19843, 19DM05672, 18FM16504, 18FM16506, 18LM10415, 19CM08208, 19CM19760, 19EM09578, 19EM09588, 19EM09588A, 18KM04390  71332256, Lot Numbers: 18GM07672, 18MM07589, 18MM07599, 18MM07622, 19BM12639, 18FM11173, 18FM11177, 18GM16978, 18MM07597, 19BM12636, 19EM09583, 18MM07597A  71332258, Lot Numbers: 18EM23223, 18FM02458, 18GM09584, 18GM16981, 18GM18527, 18GM18527B, 18GM18527C, 19CM11413, 19EM03998, 19EM03999, 18EM23220, 18LM17983, 18LM17984, 19BM07201, 19BM07202, 19BM07214, 19CM11417, 19DM12931, 19DM12936, 19EM04000, 19EM04001, 19CM11417A  71332260, Lot Numbers: 18HM08736, 18HM16488, 18FM02468, 8FM02468B,  18FM21552, 18HM19141, 18HM16487, 18HM16487A   71332262, Lot Numbers: 19EM11295, 19EM11296, 18MM02014  71332264, Lot Numbers: 19EM17718  
Recalling Firm/
Manufacturer		 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 1450 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.
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