REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, S
FDA device recall Z-0581-2014 · posted 2013-12-26 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 38 units
- Distribution
- Distributed in China and Spain.
- Date initiated
- 2013-11-25
- Date posted
- 2013-12-26
- Date terminated
- 2017-02-01
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE (K012787) | Smith & Nephew, Inc. | 2002-03-15 |