Z-1744-2015 Class II Terminated
FDA device recall Z-1744-2015 was initiated by BIOMET FRANCE S.A.R.L. on May 14, 2015 and is designated Class II. 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 surger… The recall status is terminated (terminated October 27, 2015). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2015
- Initiation Date
- May 14, 2015
- Termination Date
- October 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
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.
Distribution Pattern
Nationwide distribution to MD only
Code Information
Catalog number: 419500 Lot number: 0101296012