Z-1410-2017Class III

The UNI-CP System; Model Number: 330230SND

Name: Z-1410-2017 The UNI-CP System; Model Number: 330230SND
Creator: Integra LifeSciences Corp.
Published: 2017-01-25
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2017-01-25 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. began a recall of The UNI-CP System; Model Number: 330230SND on 2017-01-25. FDA classified it as Class III and gives the reason as "The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1410-2017
Classification: Class III
Status: Terminated
Initiated: 2017-01-25
Posted: 2017-03-04
Terminated: 2017-11-08
Recalling firm: Integra LifeSciences Corporation
Product: The UNI-CP System; Model Number: 330230SND.
Product code: JDR Staple, Fixation, Bone
Reason for recall: The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
Root cause tag: design
FDA root cause: Device Design
Action: Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.
Quantity in commerce: 39 units
Distribution: Nationwide
Product codes and lots: Lot # FEDT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1410-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1410-2017	Class III	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-04

Product code JDR

K011716Class IIThe Uni-Clip StapleNew Deal, S.A. / cleared 2001-08-30

MDM coverage of this record lists here, newest first.

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)