FDA-Device2016-06-22Class II
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.
Integra LifeSciences Corp.
Hazard
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
Sold states
US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
Affected count
71 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1965-2016Don't want to check this manually?
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