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EASYMIX® vacuum pump I

OSARTIS GmbH · Model 02-0401 · UDI-DI 04260056881633

JDY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room.

Recalls

Date	Firm	Reason
2008-06-30	Zimmer Inc.	The cartridge is brittle and at increased risk of breakage.

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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.