Recall Z-1744-2015— BIOMET FRANCE S.A.R.L.
Class II · Terminated
Class II FDA medical device recall by BIOMET FRANCE S.A.R.L., initiated 2015-05-14, terminated 2015-10-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- BIOMET FRANCE S.A.R.L.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-14
- Terminated
- 2015-10-27
- Firm location
- Valence Cedex 9, N/A, France
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.