Z-2335-2020Class II

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes...

Name: Z-2335-2020 smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes...
Creator: Smith & Nephew, Inc.
Published: 2020-04-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-04-22 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM... on 2020-04-22. FDA classified it as Class II and gives the reason as "A manufacturing error resulted in out of specification R3 Acetabular Shells". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2335-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-22
Posted: 2020-06-09
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.
Product code: MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Reason for recall: A manufacturing error resulted in out of specification R3 Acetabular Shells
Root cause tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 1766 devices
Distribution: Worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2335-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2332-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2333-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2334-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2335-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09
Z-2336-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-17	2020-06-09

Product code MBL

K070756Class IISmith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. / cleared 2007-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)