Synthes External Fixation System Tube to Tube Clamp — Class II medical device recall Z-0277-2013
Terminated recall by Synthes USA HQ, Inc., reported 2012-11-21, distributed nationwide. The insert provided with the product for the specific lot number indicates that this product is MR safe. This
| Recall number | Z-0277-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2012-09-28 |
| Classified | 2012-11-13 |
| Reported by FDA | 2012-11-21 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 8 |
| Lot numbers | 6800599 |
| Model numbers | 390.007 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0277-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.