FDA Device recall Z-2334-2020

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM…

FDA Device
Class II
ongoing
Published 2020-06-17

On 2020-06-17 the FDA classified a Class II recall of smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM… by Smith And Nephew, citing A manufacturing error resulted in out of specification R3 Acetabular Shells.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2334-2020
Classification	Class II
Status	ongoing
Initiated	2020-04-22
Published	2020-06-17
Last updated	2026-09-13 11:55 UTC
Company	Smith And Nephew
Distribution	n/a

Product

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.

Reason

A manufacturing error resulted in out of specification R3 Acetabular Shells

Identifiers

code_info	71331942, Lot Numbers: 18HM20692, 18EM07919 71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19D… 71331942, Lot Numbers: 18HM20692, 18EM07919 71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19DM17868, 19DM17872, 19EM20020, 18GM18521, 18JM14573, 19DM10929, 19DM10931, 19DM17866, 19DM17869, 19DM17871, 19EM20018 71331948, Lot Numbers: 18GM16878, 18JM08597, 18JM08598, 18JM08599, 18JM08600, 18MM01816, 18MM01825, 19BM08346, 19BM08353, 19BM08377, 19BM21631, 19BM21634, 19BM21642, 19CM00707, 19CM00729, 19DM17874, 19DM17875, 19DM17879, 19EM05719, 19EM05725, 19EM05727, 19EM05734, 19EM05735, 19EM05739, 19EM11935, 19EM19991, 19EM19995, 18GM16862, 19BM21637, 18GM16845, 18GM16860, 18GM16874, 18JM18993, 18DM20332, 18LM03848, 18MM01811, 18MM01818, 18LM03812, 18LM03851, 19BM08371, 19BM08373, 19BM21639, 19BM21643, 19CM00735, 19DM10935, 19DM17873, 19DM17878, 19EM11942, 19EM11943, 18LM17674, 19EM05738, 18GM04745, 18GM04750 71331950, Lot Numbers: 18FM17581, 18HM16477, 18HM16477A, 18HM16490, 18JM12754, 18JM12755, 18JM12814, 18KM08903, 18KM08903A, 18LM02612, 18LM02630, 19BM1

code_info

71331942, Lot Numbers: 18HM20692, 18EM07919 71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19D…

71331942, Lot Numbers: 18HM20692, 18EM07919 71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19DM17868, 19DM17872, 19EM20020, 18GM18521, 18JM14573, 19DM10929, 19DM10931, 19DM17866, 19DM17869, 19DM17871, 19EM20018 71331948, Lot Numbers: 18GM16878, 18JM08597, 18JM08598, 18JM08599, 18JM08600, 18MM01816, 18MM01825, 19BM08346, 19BM08353, 19BM08377, 19BM21631, 19BM21634, 19BM21642, 19CM00707, 19CM00729, 19DM17874, 19DM17875, 19DM17879, 19EM05719, 19EM05725, 19EM05727, 19EM05734, 19EM05735, 19EM05739, 19EM11935, 19EM19991, 19EM19995, 18GM16862, 19BM21637, 18GM16845, 18GM16860, 18GM16874, 18JM18993, 18DM20332, 18LM03848, 18MM01811, 18MM01818, 18LM03812, 18LM03851, 19BM08371, 19BM08373, 19BM21639, 19BM21643, 19CM00735, 19DM10935, 19DM17873, 19DM17878, 19EM11942, 19EM11943, 18LM17674, 19EM05738, 18GM04745, 18GM04750 71331950, Lot Numbers: 18FM17581, 18HM16477, 18HM16477A, 18HM16490, 18JM12754, 18JM12755, 18JM12814, 18KM08903, 18KM08903A, 18LM02612, 18LM02630, 19BM1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2334-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.