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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smith & Nephew, Inc.
- Reason for Recall:
- A manufacturing error resulted in out of specification R3 Acetabular Shells
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2335-2020
Related Recalls
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
The Bipolar assembly contains an oversized Retainer Ring.