PlainRecalls
FDA Devices Moderate Class II 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.

Reported: January 1, 2014 Initiated: November 25, 2013 #Z-0581-2014

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.

Details

Recalling Firm
Smith & Nephew Inc
Units Affected
38 units
Distribution
Distributed in China and Spain.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Smith & Nephew Inc. Units affected: 38 units.
Why was this product recalled?
One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0581-2014.