Integra UNI-CP System Recalled for Incorrect Labeling
Integra LifeSciences Corp. is recalling 39 units of the UNI-CP System due to incorrect labeling on the plate.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III and involves a labeling error, which fits the rubric criteria for Low severity (documentation issues, packaging-only problems).
Plain-English summary
Integra LifeSciences Corp. is recalling 39 units of the UNI-CP System, Model Number 330230SND, Lot # FEDT. The recall was initiated after the firm received a complaint from a non-US sales representative in France regarding an incorrect label on the UNI-CP plate.
The affected products were distributed nationwide. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers with this product should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- The UNI-CP System; Model Number: 330230SND.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 39
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 (1)
- Lot # FEDT
Distribution
Distributed nationwide across the United States.
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