Recall Z-0581-2014 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Smith & Nephew Inc
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.
| Date | Dec 26, 2013 (initiated Nov 25, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | All affected sales staff was notified of problem and the recall via email on 11/25/2013. There were no US hospitals affected by this recall. |
| Quantity | 38 units |
| Distribution | Distributed in China and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012787 | VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE Smith & Nephew, Inc., Mar 15, 2002 |