smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL — Class II medical device recall Z-2331-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-06-17. A manufacturing error resulted in out of specification R3 Acetabular Shells
| Recall number | Z-2331-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-04-22 |
| Classified | 2020-06-09 |
| Reported by FDA | 2020-06-17 |
| Quantity | 1,267 devices |
| Reason classes | specification failure |
| Lot numbers | 18GM07436, 18GM07437, 18GM07438, 18GM07445, 18GM07469, 18GM07522, 18GM07533, 18HM01685, 18HM19101, 18HM19116, 18HM19117, 18HM19123, 18HM20691, 18JM10154, 18JM10154A, 18JM13874, 18JM13875, 18JM15940, 18JM15941, 18JM15947, 18JM15949, 18JM15949A, 18JM15950, 18KM00744, 18KM00775, 18KM00779, 18KM00833, 18KM03144, 18KM03147, 18KM03148, 18KM04226, 18KM04250, 18KM04251, 18KM04252, 18KM04253, 18KM04254, 18KM06667, 18KM06675, 18KM06676, 18KM06680 and 96 more |
Product
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
Reason for recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2331-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.