FDA Device recall Z-2332-2020

smith&nephew R3 ZERO 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 ZERO 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-2332-2020
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 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.

Reason

A manufacturing error resulted in out of specification R3 Acetabular Shells

Identifiers

code_info	71332242, Lot Numbers: 18HM20693, 18HM20693A 71332246, Lot Numbers: 19EM17729, 19EM17730, 19EM17730A 71332248, Lo… 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, 18LM1041

code_info

71332242, Lot Numbers: 18HM20693, 18HM20693A 71332246, Lot Numbers: 19EM17729, 19EM17730, 19EM17730A 71332248, Lo…

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, 18LM1041

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-2332-2020%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.