Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2386-2016)

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 Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219

Product Classification:

Class II

Date Initiated: July 20, 2016

Date Posted: August 17, 2016

Recall Number: Z-2386-2016

Event ID: 74757

Reason for Recall:

Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

Status: Terminated

Product Quantity: 495 units

Code Information:

Lot # GT0420 and GT0419

Distribution Pattern:

US Distribution to the states of : FL, VA, OK, CO, DC and IN.

Voluntary or Mandated:

Voluntary: Firm initiated