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Home › Auxein Medical Private Limited › 2.4mm Wise-Lock “T” Distal Radius Dorsal Plate, (3 Head Holes), 4 Holes

2.4mm Wise-Lock “T” Distal Radius Dorsal Plate, (3 Head Holes), 4 Holes

Auxein Medical Private Limited · Model TI-M08.04 · UDI-DI 08903993200254

HRS
1
510(k) clearances
39,163
Adverse events (74 deaths)
287
Recalls
516
Facilities

Description

The Radius plates are made of titanium alloy and are designed various length configurations. The plates are contoured to provide a close fit with radius system.

Recalls

DateFirmReason
2026-08-18Wright Medical Technology, Inc.Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve
2026-05-28Acumed LLCDue to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23I.T.S. GmbHUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

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Data 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.