Device 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.
Z-2336-2020
Product summary
- Event
- Event 85637
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58 devices
- Official record key
device-enforcement:Z-2336-2020
Official wording
Reason: A manufacturing error resulted in out of specification R3 Acetabular Shells
Code information: 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
Distribution pattern: Worldwide
Derived failure modes
-
Manufacturing or process control
manufacturing error
-
Potency or specification failure
out of specification