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EASYMIX® Nozzle revision

OSARTIS GmbH · Model 02-0105 · UDI-DI 04260056880919

JDZ Prescription

510(k) clearances

998

Adverse events (4 deaths)

Recalls

131

Facilities

Description

The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing system. The mixing system is composed of the mixing cartridge with the socket, the mixing paddle with the handle, the funnel, the femoral pressurizer, the tubing to the vacuum pump and the standard nozzle. The EASYMIX® Nozzle revision is longer and of larger diameter than the EASYMIX® standard nozzle.

Recalls

Date	Firm	Reason
2026-03-30	Zimmer, Inc.	Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised
2026-03-25	Heraeus Medical GmbH (Dental Division)	Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing
2026-03-25	Heraeus Medical GmbH (Dental Division)	Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2017-11-09	Stryker Instruments Div. of Stryker Corporation	Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
2013-11-01	Stryker Instruments Div. of Stryker Corporation	On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product was going to be plac

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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.