FDA-Device2015-06-17Class II
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
BIOMET FRANCE S.A.R.L.
Hazard
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 necessitate revision surgery if the pin falls into the surgical site and is not detected.
Sold states
Nationwide distribution to MD only
Affected count
3
Manufactured in
plateau de lautagne, valence cedex 9, Valence Cedex 9, N/A, France
Products
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1744-2015Don't want to check this manually?
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