REFLECTION — Class II medical device recall Z-0581-2014
Terminated recall by Smith & Nephew Inc, reported 2014-01-01. One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not t
| Recall number | Z-0581-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2013-12-26 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2017-02-01 |
| Countries outside the US | CN, ES |
| Quantity | 38 units |
| Lot numbers | 12BM04836 |
| Model numbers | 71742854 |
Product
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
Reason for recall
One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the 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-0581-2014. 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.