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Orthex External Fixation System
ORTHOPEDIATRICS CORP. · Model ORTHEXSW · UDI-DI 00840194428002
OSN
Prescription
2
510(k) clearances
22
Adverse events
2
Recalls
38
Facilities
Description
Orthex P&C Software v2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-12 | OrthoPediatrics Corp | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regenerati |
| 2017-12-13 | Smith & Nephew, Inc. | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.