TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2 — Class II medical device recall Z-1965-2016
Terminated recall by Integra LifeSciences Corp., reported 2016-06-22, distributed in CO, FL, IL, MI, NJ, NY, SC, TX…. As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot
| Recall number | Z-1965-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2016-05-10 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-12-16 |
| Distributed | CO, FL, IL, MI, NJ, NY, SC, TX, VA |
| Quantity | 71 units |
| Lot numbers | UP07E2, UP09D3, UP15H2 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1965-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.