Z-2684-2016Class II

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

Name: Z-2684-2016 INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2016-08-04
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2016-08-04 / Terminated

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile on 2016-08-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2684-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-04
Posted: 2016-08-29
Terminated: 2016-12-19
Recalling firm: Integra Pain Management
Product: INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
Product code: CAZ Anesthesia Conduction Kit
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.
FDA root cause: Other
Action: Integra sent an Urgent Medical Device letter dated August 4, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return unused, affected product. Confirmation of the recall notification delivery via delivery verifiable email; Return of Recall Acknowledgement form; Return & disposition of unused, affected product, if the customer in their response indicates they have affected devices. Any products returned to Integra as a result of the recall will be stored in a segregated, labeled area. Recalled products that are returned will be dispositioned as scrap and destroyed. Any Lidocaine returned with the products will be dispositioned as directed in the Hospira Inc. Drug Recall Notification. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210. For further questions, please call (801) 886-9505.
Quantity in commerce: 200 packages (20 cases)
Distribution: US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee.
Product codes and lots: The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2684-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2684-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-29

Product code CAZ

K943319Class IIGertie Marx Epi-Spinal TraySpinal Specialties, Inc. / cleared 1995-06-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)