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Mini and Micro Fragments Reconstruction System - GMReis

GM DOS REIS INDUSTRIA E COMERCIO LTDA · Model Micro Screw · UDI-DI 07899258602455

HRSHWC Prescription
10
510(k) clearances
38,974
Adverse events (73 deaths)
286
Recalls
516
Facilities

Description

MICRO VERSA SCREW TORXDRIVE TI Ø1.5x7.0mm MICRO VERSA SCREW TORXDRIVE TI Ø1.5x7.0mm

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.