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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 67042
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in China and Spain.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Batch No. 12BM04836 Class II One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell. 38 units Z-0581-2014