Recall Z-2684-2016— Integra LifeSciences Corp. d.b.a. Integra Pain Management

Name: FDA recall Z-2684-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-04

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2016-08-04, terminated 2016-12-19. It names one FDA 510(k) clearance: K943319. Product: INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.. Reason: Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays..

Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Terminated: 2016-12-19
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K943319 — GERTIE MARX EPI-SPINAL TRAYSpinal Specialties, Inc.·cleared 1995-06-30

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

INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.

Reason for recall

Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.

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