Reported Jun 17, 2015 · Terminated

The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement…

Biomet France S.a.r.l.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BIOMET FRANCE S.A.R.L. · plateau de lautagne · Valence Cedex 9, N/A · N/A

Is this the product you have?

  • 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.
Lot codes and dates
  • Catalog number419500
  • Lot number0101296012
Amount recalled
3

Where it was sold

  • Nationwide
  • MD

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 27, 2015 · Data as of Sep 19, 6:06 PM UTC

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