FDA Device recall Z-0581-2014
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc by Smith And Nephew, citing one batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0581-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-25 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
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
One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
Identifiers
| code_info | Batch No. 12BM04836 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0581-2014%22
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