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SYNTHES (U.S.A.) LP · Model 02.222.114 · UDI-DI 10886982055880

HRSJDPHWC Prescription
1
510(k) clearances
38,974
Adverse events (73 deaths)
286
Recalls
516
Facilities

Description

5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/14MM

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.