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.
This recall is currently active, issued April 22, 2020. It was issued by Smith & Nephew Inc.
- Company
- Smith & Nephew Inc
- Recall Initiated
- April 22, 2020
- Recall Number
- Z-2336-2020
- Quantity
- 58 devices
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
Distribution
Worldwide
Lot / Code Info
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
Root 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.