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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description 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
Recall Number Z-1132-2013
Classification Class II
Code Info Lot Number 12FM12182
Product Distributed Qty 23 units
Reason For Recall 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).

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 E-Mail
Distribution Pattern Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
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