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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64669
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-06
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery Lot Number 12FM12182 Class II One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter). 23 units Z-1132-2013