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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63446
Product Type Devices
Status Ongoing
Recalling Firm Synthes USA HQ, Inc.
City West Chester
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-including the states of CA, MN, NC, and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening. Part number 390.007, Lot number 6800599 Class II The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. 8 Z-0277-2013