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Novo Surgical Inc.

NOVO SURGICAL, INC. · Model N8831-16 · UDI-DI 00842331168079

GAC Prescription
2
510(k) clearances
32
Adverse events
1
Recalls
180
Facilities

Description

polokoff rasp, double-ended, 3.0 mm & 4.0 mm ends, 7" (17.5 cm)

Recalls

DateFirmReason
2011-12-29Stryker Howmedica Osteonics Corp.Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.

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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.