Z-1965-2016Class II

TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is...

Name: Z-1965-2016 TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is...
Creator: Integra LifeSciences Corp.
Published: 2016-05-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-05-10 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2016-05-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1965-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-10
Posted: 2016-06-14
Terminated: 2016-12-16
Recalling firm: Integra LifeSciences Corporation
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.
Product code: HRS Plate, Fixation, Bone
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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Integra Lifesciences, sent an "Urgent: Voluntary Medical Device Recall" letter dated 5/10/16 to affected consignees/customers via traceable courier service on 5/10/16. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using and distributing product immediately; complete and return the Recall Acknowledgement and Return Form via fax to 1-609-275-9445 or email to [email protected], even if you do not have any of the product. Should you have any questions, please contact Customer Service at 1-866-854-8300.
Quantity in commerce: 71 units
Distribution: US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
Product codes and lots: Lot UP15H2, Lot UP09D3, Lot UP07E2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1965-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1965-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14

Product code HRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)