FDA Device recall Z-2331-2020

smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48M…

FDA Device
Class II
ongoing
Published 2020-06-17

On 2020-06-17 the FDA classified a Class II recall of smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48M… 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-2331-2020
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 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.

Reason

A manufacturing error resulted in out of specification R3 Acetabular Shells

Identifiers

code_info	71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19A… 71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829 71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A 71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A 71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM

code_info

71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19A…

71331842, Lot Numbers: 18HM20691, 18LM09819, 18KM1572 71331848, Lot Numbers: 18HM01685, 19AM15804, 19AM15805, 19AM15809, 19AM15828, 19AM15829 71331850, Lot Numbers: 18LM00667, 18LM00668, 18LM00670, 18LM00671, 18LM00702, 18LM00668A, 18LM00671A 71331852, Lot Numbers: 19EM10292, 18KM20315, 18KM15739, 18KM20284, 18LM17941, 18LM02317, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM06667, 18KM06675, 18KM06676, 18KM06680, 18KM06681, 18KM06682, 18KM13594, 18KM13632, 18KM15736, 18KM15737, 18KM15738, 18KM20281, 18KM20289, 18KM20291, 18KM20292, 18KM24785, 18KM24792, 18KM24795, 18KM24805, 18LM02315, 18LM02337, 18LM17942, 18LM17946, 18KM20281A, 18LM07653, 18KM15736A, 18LM14077, 18KM24785A, 18KM20293A 71331854, Lot Numbers: 18JM13875, 18mm08723, 18JM13874, 19AM17866, 19AM17869, 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18KM03144, 18KM03147, 18KM03148, 18KM23654, 18KM23655, 18KM23662, 18MM08650, 18MM08663, 18MM08676, 18MM08678, 18MM08683, 18MM

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-2331-2020%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.