Recall Z-0581-2014— Smith & Nephew Inc

Name: FDA recall Z-0581-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-25

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-11-25, terminated 2017-02-01. It names one FDA 510(k) clearance: K012787. 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..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Terminated: 2017-02-01
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K012787 — VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINESmith & Nephew, Inc.·cleared 2002-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.