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Versalock Periprosthetic Femur Plates System-GMReis

GM DOS REIS INDUSTRIA E COMERCIO LTDA · Model VA Screw · UDI-DI 07899258600666

JDPHWCJDQHRS Prescription
2
510(k) clearances
876
Adverse events (2 deaths)
2
Recalls
14
Facilities

Description

VERSALOCK VARIABLE ANGLE SCREW T25 Ø5.0x70.0mm Ti

Recalls

DateFirmReason
2014-02-05Synthes, Inc.Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848
2013-05-29Synthes USA HQ, Inc.A plate was inadvertently released to a sales consultant that was restricted for sale.

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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.