—#181435

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.

FDA product code: MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070756
Affected lot / code info: 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

Why it was recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2020-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181435. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.