R3 — Class II medical device recall Z-1735-2015
Terminated recall by Smith & Nephew, Inc., reported 2015-06-17, distributed nationwide. The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking
| Recall number | Z-1735-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2015-05-06 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2022-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, ES |
| Quantity | 17 units |
| Lot numbers | 14HM08235, 14KM08473 |
| Model numbers | 71339152 |
Product
R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
Reason for recall
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
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-1735-2015. 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.