Recall Z-2336-2020
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 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.
Codes / lots: 71338733, Lot Numbers: 19DM28110, 19DM28106, 19DM28106A 71338734, Lot Numbers: 19DM28114 71338735, Lot Numbers: 19DM28116 71338736, Lot Numbers: 19EM19673, 19EM19683, 19EM19678 71338737, Lot Numbers: 18JM12872 71338738, Lot Numbers: 18FM02387 71338740, Lot Numbers: 18JM02713 71338741, Lot Numbers: 19AM22770, 19AM22770A
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-2336-2020
- Initiated
- April 22, 2020
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Quantity
- 58 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-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 |