smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED… — Class II medical device recall Z-2336-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-06-17. A manufacturing error resulted in out of specification R3 Acetabular Shells
| Recall number | Z-2336-2020 |
|---|---|
| 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 | 58 devices |
| Reason classes | specification failure |
| Lot numbers | 18FM02387, 18JM02713, 18JM12872, 19AM22770, 19AM22770A, 19DM28106, 19DM28106A, 19DM28110, 19DM28114, 19DM28116, 19EM19673, 19EM19678, 19EM19683, 71338734, 71338735, 71338736, 71338737, 71338738, 71338740, 71338741 |
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 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-2336-2020. 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.