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ebner 502 Handle Straight Head

MAXILON LABORATORIES INC · Model 10325-01 · UDI-DI 00860002195032

GACEMI
2
510(k) clearances
33
Adverse events
1
Recalls
180
Facilities

Description

The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of a stainless steel handle and blade (blade labeled for single use). The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle's head. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl. Blades are standardized so that ebner 500 BLADEs can be used with any ebner 500 HANDLE (501, 502... 5nn). Before the clinician's first case, he should become familiar with the instrument including the mounting and removal of the blade.

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.