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BIOMET FRANCE S.A.R.L. recalls The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement
Recalled June 17, 2015 · FDA recall Z-1744-2015 · 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. · FDA Class II
Units
3
Sold at
Nationwide distribution to MD only
Description
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.
Product
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.
Manufacturer(s)
BIOMET FRANCE S.A.R.L.
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →