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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65653
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-21
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Worldwide Distribution - USA, including the states of CT, VA, FL, TX, CO and MS. and the country of Jamaica.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Lot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R Class II Difficulty removing screws from the Invue caddies. 8 Z-1933-2013
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