Smith&nephew R3 Multi Hole Hemispherical Stiktite recall
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM…
Why was Smith&nephew R3 Multi Hole Hemispherical Stiktite recalled?
A manufacturing error resulted in out of specification R3 Acetabular Shells
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 1766 devices
- Distribution
- Worldwide
- Recall date
- June 17, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)