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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