Enforcement Report - Week of November 21, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0277-2013 |
| Classification | Class II |
| Code Info | Part number 390.007, Lot number 6800599 |
| Product Distributed Qty | 8 |
| Reason For Recall | 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. |
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 | Letter |
| Distribution Pattern | Nationwide Distribution-including the states of CA, MN, NC, and TN. |
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