Smith & Nephew, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Smith & Nephew, Inc. is recalling smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the followi due to A manufacturing error resulted in out of specification R3 Acetabular Shells. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A manufacturing error resulted in out of specification R3 Acetabular Shells
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026