Integra LifeSciences Corp. recalls TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the p…

Recall date

May 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1965-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.