Z-2336-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- April 22, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 devices
Product Description
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.
Reason for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
Distribution Pattern
Worldwide
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