Recall

Class II — Integra LifeSciences Corp.

Recalling firm	Integra LifeSciences Corporation
Registered facility	View this company's 15 registered facilities → (openFDA recall records do not name a specific facility)
Classification	Class II
Status	Terminated
Reason	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
Product	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.
Quantity	71 units
Distribution	US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
Initiated	2016-05-10
Classified	2016-06-14
Terminated	2016-12-16
Recall number	Z-1965-2016
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-1965-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74114/

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