Home › Synthes GmbH › MAXFRAME
MAXFRAME
Synthes GmbH · Model 03.313.877 · UDI-DI 10886982306241
3
510(k) clearances
22
Adverse events
2
Recalls
38
Facilities
Description
MAXFRAME(TM) POLYAXIAL STRUT GROSS ADJUST/LONG
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.