smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL — Class II medical device recall Z-2333-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-06-17. A manufacturing error resulted in out of specification R3 Acetabular Shells
| Recall number | Z-2333-2020 |
|---|---|
| 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 | 6,468 devices |
| Reason classes | specification failure |
| Lot numbers | 18GM04646, 18GM04651, 18GM04658, 18GM04669, 18GM04677, 18GM04679, 18GM06066, 18GM06120, 18GM06191, 18GM06248, 18GM06259, 18GM06259A, 18GM06367, 18GM06374, 18GM06376, 18GM06381, 18GM06384, 18GM06446, 18GM06448, 18GM06454, 18GM06460, 18GM06462, 18GM06481, 18GM07455, 18GM16200, 18GM16201, 18GM16201A, 18GM16203, 18GM16208, 18GM16210, 18GM16222, 18GM16240, 18GM16261, 18GM16275, 18GM16277, 18GM16279A, 18GM16281, 18GM16281A, 18GM16291, 18GM16291A and 460 more |
Product
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 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-2333-2020. 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.