Recall Z-2334-2020
Smith & Nephew, Inc. · initiated April 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.
Codes / lots: 71331942, Lot Numbers: 18HM20692, 18EM07919 71331946, Lot Numbers: 18GM07650, 18GM18522, 18JM01361, 18JM14484, 19DM17868, 19DM17872, 19EM20020, 18GM18521, 18JM14573, 19DM10929, 19DM10931, 19DM17866, 19DM17869, 19DM17871, 19EM20018 71331948, Lot Numbers: 18GM16878, 18JM08597, 18JM08598, 18JM08599, 18JM08600, 18MM01816, 18MM01825, 19BM08346, 19BM08353, 19BM08377, 19BM21631, 19BM21634, 19BM21642, 19CM00707, 19CM00729, 19DM17874, 19DM17875, 19DM17879, 19EM05719, 19EM05725, 19EM05727, 19EM05734, 19EM05735, 19EM05739, 19EM11935, 19EM19991, 19EM19995, 18GM16862, 19BM21637, 18GM16845, 18GM16860, 18GM16874, 18JM18993, 18DM20332, 18LM03848, 18MM01811, 18MM01818, 18LM03812, 18LM03851, 19BM08371, 19BM08373, 19BM21639, 19BM21643, 19CM00735, 19DM10935, 19DM17873, 19DM17878, 19EM11942, 19EM11943, 18LM17674, 19EM05738, 18GM04745, 18GM04750 71331950, Lot Numbers: 18FM17581, 18HM16477, 18HM16477A, 18HM16490, 18JM12754, 18JM12755, 18JM12814, 18KM08903, 18KM08903A, 18LM02612, 18LM02630, 19BM12905, 19CM15757, 19CM15761, 19CM15763, 19CM15765, 19DM06283, 19DM06289, 19DM06292, 19DM06486, 19DM10837, 19DM10842, 19DM10846, 19DM10851, 19EM11937, 19EM23519, 18FM17575, 18FM17585, 18GM01198, 18GM01198A…
Reason for recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2334-2020
- Initiated
- April 22, 2020
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Quantity
- 4172 devices
- Distribution
- Worldwide
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2331-2020 Class II | smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2332-2020 Class II | smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2333-2020 Class II | smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2335-2020 Class II | smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2336-2020 Class II | smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |