FDA-Device2014-01-01Class II

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.

Smith & Nephew Inc
Hazard

One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.

Sold states
Distributed in China and Spain.
Affected count
38 units
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2014

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