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Recall Observatory FDA recall evidence

Device product

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

Z-2684-2016

August 04, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Event
Event 74867
Status
Terminated
Classification
Class II
Quantity
200 packages (20 cases)
Official record key
device-enforcement:Z-2684-2016

Official wording

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.

Code information: The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556;

Distribution pattern: US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.