smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL — Class II medical device recall Z-2335-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-06-17. A manufacturing error resulted in out of specification R3 Acetabular Shells
| Recall number | Z-2335-2020 |
|---|---|
| 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 | 1,766 devices |
| Reason classes | specification failure |
| Lot numbers | 18DM18282, 18DM18284, 18EM01929, 18EM10564, 18EM14265, 18EM17244, 18EM17247, 18EM18375, 18EM18377, 18EM18377A, 18EM23226, 18EM23226A, 18GM04676, 18GM04678, 18GM04680, 18GM06572, 18GM06573, 18GM06581, 18GM06752, 18GM06759, 18GM07678, 18GM07679, 18GM17009, 18GM18693, 18GM18693A, 18GM18700, 18GM18700A, 18GM20396, 18GM20401, 18GM20401A, 18GM20402, 18GM20402A, 18GM21563, 18HM00298, 18HM00300, 18HM00329, 18HM00347, 18HM00347A, 18HM03514, 18HM03834 and 152 more |
Product
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 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-2335-2020. 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.