Integra Recalls NewPort MIS System Due to Potential Component Mixing
Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.
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 involves a high-risk medical device (spinal implant) where a potential mix-up of components could lead to harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corp. is recalling four units of the Integra NewPort MIS System. The affected products are the NewPort Implant Tray with Components (Model No. NWPIMP) and the NewPort Instrument Tray with Components (Model No. NWP2INSTP). The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The recall was initiated because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery. The affected serial numbers are NWP-016 for the NewPort Implant Tray with Components and NWP2-015 for the NewPort Instrument Tray with Components.
The affected units were distributed in Texas only. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 4
Distribution
Distributed in 1 state:
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