FDA Device recall Z-2336-2020
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM…
- FDA Device
- Class II
- ongoing
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM… by Smith And Nephew, citing A manufacturing error resulted in out of specification R3 Acetabular Shells.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2336-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-04-22 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
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.
Reason
A manufacturing error resulted in out of specification R3 Acetabular Shells
Identifiers
| code_info | 71338733, Lot Numbers: 19DM28110, 19DM28106, 19DM28106A 71338734, Lot Numbers: 19DM28114 71338735, Lot Numbers:…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2336-2020%22
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