Food, drugs, devices › Integra LifeSciences Corp.
Device recall: The UNI-CP System; Model Number: 330230SND.
Integra LifeSciences Corp. (Plainsboro, NJ) initiated this device recall on 25 Jan 2017; FDA lists 1 product record under event 76408, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 8 Nov 2017. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. has 79 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corp., Plainsboro, NJ.
Reason for recall
"The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1410-2017 | The UNI-CP System; Model Number: 330230SND. | 39 units | Class III | Terminated | 15 Mar 2017 |
Context
Other enforcement events for Integra LifeSciences Corp.
All 79 events for Integra LifeSciences Corp.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Nov 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.