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…

Recall date

May 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1744-2015

FDA classification

Class II

Brand / firm

BIOMET FRANCE S.A.R.L.

Sold / distributed

Nationwide distribution to MD only

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.