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Synthes USA HQ, Inc. recalls Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for l
Recalled November 21, 2012 · FDA recall Z-0277-2013 · Synthes USA HQ
Hazard
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. · FDA Class II
Units
8
Sold at
Nationwide Distribution-including the states of CA, MN, NC, and TN.
Description
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.
Product
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →