Smith & Nephew, Inc.: smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

Recall number

Z-2335-2020

Recalling firm

Smith & Nephew, Inc.

Product

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

Status

Open, Classified

Initiated

2020-04-22

Posted

not on file

Terminated

not on file

Reason

A manufacturing error resulted in out of specification R3 Acetabular Shells

Root cause

Process control

Action

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.

Quantity

1766 devices

Distribution

Worldwide

Lot, serial or model codes

71338663, Lot Numbers: 18EM10564, 18EM23226, 18EM23226A, 18HM14882, 18JM12818, 18JM12819, 18JM12819A, 18KM09644, 18LM19836, 18MM07583, 19BM10203, 19CM19574, 19CM19582, 19DM28076, 18KM25982, 18MM07580, 19DM15683, 19EM19652, 19EM19655, 19EM19656, 19EM19657, 18KM25982A, 18GM18693, 18GM18700, 18HM04587, 18HM04588, 18HM04593, 18HM14887, 18JM02705, 18GM18693A, 18GM18700A, 18HM04588A, 18HM14887A  71338664, Lot Numbers: 18JM00846, 18JM00851, 18JM03933, 18JM03964, 18KM11934, 18KM14029, 18LM19837, 18LM21024, 19AM23671, 19AM23674, 19BM12881, 19DM15685, 19DM15687, 19EM19658, 19EM19659, 19EM19660, 18GM04676, 18GM04678, 18GM04680, 18HM14311, 18EM01929, 18EM14265, 18HM05120, 18JM03940, 19DM15688, 19DM28083, 19DM28084, 19DM28085, 19DM28086, 19DM28078, 19DM28079, 19EM19661, 19EM19662, 18JM03940A, 19DM28083A, 18KM25957, 18KM25958, 19AM05159, 19AM05159A  71338665, Lot Numbers: 18GM06572, 18GM07678, 18HM16467, 18JM01340, 18JM01342, 18JM08808, 18JM13325, 18JM17690, 18JM17693, 18JM17696, 18KM21705, 19BM02834, 19BM02839, 19CM19591, 19DM28090, 19DM28098, 19DM28099, 19EM19663, 19EM19670, 18GM06573, 18GM06581, 18DM18282, 18DM18284, 18EM17244, 18EM17247, 18HM16458, 18LM11838, 19BM02835, 19BM02836, 19BM02838, 19DM28092, 19DM28094, 19DM28096, 19DM28102, 19EM19669, 19CM19858, 19AM05185, 18GM20396, 18GM20401, 18GM20402, 18GM21563, 18KM09552, 19AM05177, 19AM05188, 18GM20401A, 18GM20402A  71338666, Lot Numbers: 18HM03836, 18JM15041, 18JM12829, 18JM12830, 19BM10927, 19BM10928, 19BM10931, 19BM10932, 18HM00329, 18HM00347, 18HM00347A, 18HM03834, 18HM03836, 18JM15041, 18HM03514, 18KM25967, 18LM15102, 19BM10935, 19BM10930, 18HM03834, 18KM09561, 18LM11826, 18KM06619, 18KM09560, 18KM09562, 18KM09563  71338667, Lot Numbers: 18HM12336, 18HM12361, 18HM12384, 18JM07422, 18KM09948, 19BM07657, 19BM07662, 19BM07666, 19DM15703, 19DM15708, 19DM15711, 18EM18375, 18GM06752, 18GM07679, 18HM00298, 18HM12366, 18JM07424, 18JM12833, 18JM12857, 19BM07656, 19DM15699, 19DM15702, 18HM12366A, 18KM17057, 18KM25976, 18GM06759, 18GM17009, 18HM12363, 18KM25971, 18JM00895, 18JM05154, 18KM25971A, 18KM14060  71338668, Lot Numbers: 18EM18377, 18EM18377A, 18HM13061, 18HM13079, 18HM13079A, 18HM13079B, 18HM22354, 19BM06037, 19BM06042, 19BM06043, 18HM00300, 18HM22357, 19EM19997

510(k) numbers

["K070756"]

PMA numbers

not on file

Product code

MBL

Firm FEI

1020279

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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