Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-1965-2016)

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:

TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.

Product Classification:

Class II

Date Initiated: May 10, 2016

Date Posted: June 22, 2016

Recall Number: Z-1965-2016

Event ID: 74114

Reason for Recall:

As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. The number should be 4, it is 6. 3) The space / holder

Status: Terminated

Product Quantity: 71 units

Code Information:

Lot UP15H2, Lot UP09D3, Lot UP07E2

Distribution Pattern:

US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated