FDA Device recall Z-2333-2020

smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540…

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 HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540… 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-2333-2020
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 HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.

Reason

A manufacturing error resulted in out of specification R3 Acetabular Shells

Identifiers

code_info	71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391 71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19D… 71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391 71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19DM12898, 19DM12899 71335544, Lot Numbers: 18LM02189, 18LM02191, 18LM02192, 18MM08580, 18MM08582 71335546, Lot Numbers: 19AM10686, 19AM07909, 18MM08601, 18HM04443, 18HM04455, 18HM04461, 18HM04474, 18HM04483, 18HM04487, 18HM04488, 18HM04492, 18HM04495, 18HM04926, 18HM19845, 18HM19846, 18HM19848, 18HM19851, 18JM06297, 18JM06307, 18JM06308, 18KM17658, 18KM17659, 18KM17660, 18KM17662, 18MM08596, 18MM08602, 18MM08604, 18MM08607, 18MM08608, 18MM08609, 18MM08610, 18MM11254, 18MM11255, 19AM07907, 19AM07908, 19AM07916, 19AM07922, 18HM04443A, 18HM04455A, 18HM04488A, 18KM17662A, 19AM07922A, 18HM20664 71335548, Lot Numbers: 18LM19747, 19EM11800, 18LM13809, 18JM12746, 18KM09504, 18KM09498, 18KM09497, 19AM15831, 18LM19745, 18KM20266, 18MM14693, 18MM14703, 18MM14704, 18MM14697, 18LM13809A, 18MM01152, 18JM12746A, 18MM14703A, 18KM09502, 18LM13799, 18GM04646, 18GM04651, 18GM04

code_info

71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391 71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19D…

71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391 71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19DM12898, 19DM12899 71335544, Lot Numbers: 18LM02189, 18LM02191, 18LM02192, 18MM08580, 18MM08582 71335546, Lot Numbers: 19AM10686, 19AM07909, 18MM08601, 18HM04443, 18HM04455, 18HM04461, 18HM04474, 18HM04483, 18HM04487, 18HM04488, 18HM04492, 18HM04495, 18HM04926, 18HM19845, 18HM19846, 18HM19848, 18HM19851, 18JM06297, 18JM06307, 18JM06308, 18KM17658, 18KM17659, 18KM17660, 18KM17662, 18MM08596, 18MM08602, 18MM08604, 18MM08607, 18MM08608, 18MM08609, 18MM08610, 18MM11254, 18MM11255, 19AM07907, 19AM07908, 19AM07916, 19AM07922, 18HM04443A, 18HM04455A, 18HM04488A, 18KM17662A, 19AM07922A, 18HM20664 71335548, Lot Numbers: 18LM19747, 19EM11800, 18LM13809, 18JM12746, 18KM09504, 18KM09498, 18KM09497, 19AM15831, 18LM19745, 18KM20266, 18MM14693, 18MM14703, 18MM14704, 18MM14697, 18LM13809A, 18MM01152, 18JM12746A, 18MM14703A, 18KM09502, 18LM13799, 18GM04646, 18GM04651, 18GM04

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-2333-2020%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.