Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2296-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.

Product Classification:

Class II

Date Initiated: July 1, 2016

Date Posted: August 3, 2016

Recall Number: Z-2296-2016

Event ID: 74583

Reason for Recall:

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Status: Terminated

Product Quantity: 27 units

Code Information:

Lot # PN625.

Distribution Pattern:

Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.

Voluntary or Mandated:

Voluntary: Firm initiated