FDA-Device2017-03-15Class III

The UNI-CP System; Model Number: 330230SND.

Integra LifeSciences Corp.
Hazard

The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

Sold states
Nationwide
Affected count
39 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
The UNI-CP System; Model Number: 330230SND.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1410-2017

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