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Terminated

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.

FDA Recall Z-0581-2014 · Posted 2013-12-26

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLPH
Date Initiated2013-11-25
Date Terminated2017-02-01
Product Quantity38 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Distributed in China and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012787VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINESmith & Nephew, Inc. · 2002-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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