Recall Z-2332-2020
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 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 Orthopedic implant component.
Codes / lots: 71332242, Lot Numbers: 18HM20693, 18HM20693A 71332246, Lot Numbers: 19EM17729, 19EM17730, 19EM17730A 71332248, Lot Numbers: 18MM01856, 19BM08386, 19DM17884, 19DM17885, 19DM17890, 19EM11946, 19EM11947, 19DM17881, 18GM04752, 18GM04753, 18HM00807 71332250, Lot Numbers: 18JM05436, 18JM05435, 18JM05436, 19BM17964, 19DM06430, 19DM06500, 19EM03960, 18FM17594, 18GM01199, 18EM13916, 18EM13934, 18JM12796, 18JM12800, 19BM17961, 19CM15771, 19EM03956, 19EM03970, 18EM13916A, 18EM13916B, 18FM00218 71332252, Lot Numbers: 18FM02450, 18FM11167, 18GM09577, 18HM15279, 18HM15304, 18HM23477, 18HM23481, 18JM12802, 18JM12811, 18KM03172, 18LM10404, 18LM10407, 19DM21921, 19DM21927, 19EM09563, 19EM09574, 18FM01063, 18GM01228, 18GM04749, 18GM06567, 18GM17030, 18EM06114, 18EM06116, 18FM01038, 18FM00235, 18MM02061, 18MM05779, 19DM21920, 19DM21922, 19DM21925, 19DM21920A 71332254, Lot Numbers: 18FM02451, 18GM16977, 18HM15323, 18JM08634, 18JM08635, 18JM08636, 18LM10411, 18LM10411A, 18LM10411B, 18LM10414, 18MM10067, 18MM10067A, 18MM10070, 18MM10127, 18MM10127A, 18MM10144, 19BM06673, 19BM16061, 19BM16064, 19BM16066, 19BM16067, 19BM16068, 19CM04082, 19CM04084, 19CM08204, 19CM08206, 19CM08207, 19CM08209, 19CM08211…
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-2332-2020
- Initiated
- April 22, 2020
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Quantity
- 1450 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-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-2334-2020 Class II | smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured…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 |