R3 — Class II medical device recall Z-1928-2013
Terminated recall by Smith & Nephew Inc, reported 2013-08-14, distributed in FL, IA, IN, KY, MI, MO, NY, OR…. One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62
| Recall number | Z-1928-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2013-05-29 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2016-03-22 |
| Distributed | FL, IA, IN, KY, MI, MO, NY, OR, PA, TN, TX, WA, WI |
| Countries outside the US | AU, BE, CA, CL, DE, GB, IN, PL, RO, VE, ZA |
| Quantity | 53 units |
| Lot numbers | 12FM00603 |
| Model numbers | 71335762 |
Product
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
Reason for recall
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
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-1928-2013. 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.