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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis

ORTHO SOLUTIONS HOLDINGS LIMITED · Model OS292100H · UDI-DI 05055662935271

HRS
1
510(k) clearances
38,818
Adverse events (73 deaths)
286
Recalls
514
Facilities

Description

K-WIRE TROCAR TIP 1.0MM X 70MM

Recalls

DateFirmReason
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).
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.