| Class 2 Device Recall smith&hephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MBL
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