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EASYMIX cement injector
OSARTIS GmbH · Model 02-0504-04 · UDI-DI 04260056881251
10
510(k) clearances
458
Adverse events (5 deaths)
5
Recalls
99
Facilities
Description
The cement injector is used to apply bone cements. It is operated manually and provides a secure environment for the cartridge and a constant discharge of bone cement during application. It is made of high-grade stainless steel and designed for reuse and resterilisation. The EASYMIX® cement injector is intended to be used with the EASYMIX® mixing system to apply PMMA bone cements.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-02-28 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation |
| 2015-08-20 | Orthovita, Inc., dBA Stryker Orthobiologics. | Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration |
| 2015-05-14 | BIOMET FRANCE S.A.R.L. | The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessi |
| 2012-01-13 | Stryker Instruments Div. of Stryker Corporation | The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proxi |
| 2011-03-31 | Orthovita, Inc. | Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. Th |
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