Recall Z-1410-2017— Integra LifeSciences Corp.

Name: FDA recall Z-1410-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-25

Class III · Terminated

Class III FDA medical device recall by Integra LifeSciences Corp., initiated 2017-01-25, terminated 2017-11-08. It names one FDA 510(k) clearance: K011716. Product: The UNI-CP System; Model Number: 330230SND.. Reason: The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect..

Recalling firm: Integra LifeSciences Corp.
Classification: Class III
Status: Terminated
Initiated: 2017-01-25
Terminated: 2017-11-08
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K011716 — THE UNI-CLIP STAPLENew Deal, S.A.·cleared 2001-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The UNI-CP System; Model Number: 330230SND.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.