FDA Device recall Z-0277-2013
Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007
- FDA Device
- Class II
- terminated
- Published 2012-11-21
On 2012-11-21 the FDA classified a Class II recall of Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007 by Synthes Usa Hq, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0277-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-28 |
| Published | 2012-11-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Part number 390.007, Lot number 6800599 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0277-2013%22
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