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AESCULAP

Aesculap AG · Model OL406R · UDI-DI 04038653178476

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

Description

FOMON Bone Rasp, 8 1/2" (215 mm), double ended, toothed (fine coarse), width: 6,50 mm, 7,50 mm

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.