Integra Recalls Spinal Trays Due to Lidocaine Component Issue
Integra LifeSciences is recalling specific lots of Spinal Trays because they contain affected Hospira 5% Lidocaine HCL.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medication component (Lidocaine) in a sterile medical device, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling the INTEGRA Spinal Tray, Catalogue No. 3404875. The recall involves 200 packages (20 cases) of the sterile spinal trays.
The recall is being conducted because the affected trays contain Hospira 5% Lidocaine HCL, a component that is subject to its own recall. The affected lots were manufactured on February 11, 2015, and July 11, 2015. The specific lot numbers are W1503004, S1501531, and S1505556.
The affected products were distributed in the United States to the states of Ohio and California. There were no foreign, government, VA, or military consignees. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
- Category
- Medical Device — Spinal Trays
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- S1501531
- S1505556
Distribution
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