Integra LifeSciences Corp.: Medical Device Recall in 2013 - (Recall #: Z-1685-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.

Product Classification:

Class II

Date Initiated: February 1, 2013

Date Posted: July 17, 2013

Recall Number: Z-1685-2013

Event ID: 65503

Reason for Recall:

The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.

Status: Terminated

Product Quantity: 154 screwdrivers were distributed; 67 screwdriver tips were distributed.

Code Information:

The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated