BIOMET FRANCE S.A.R.L.: Medical Device Recall in 2015 - (Recall #: Z-1744-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 14, 2015

Date Posted: June 17, 2015

Recall Number: Z-1744-2015

Event ID: 71365

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.

Status: Terminated

Product Quantity: 3

Code Information:

Catalog number: 419500 Lot number: 0101296012

Distribution Pattern:

Nationwide distribution to MD only

Voluntary or Mandated:

Voluntary: Firm initiated