Food, drugs, devices › Integra LifeSciences Corp.
Device recall: NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for
Integra LifeSciences Corp. (Princeton, NJ) initiated this device recall on 7 Feb 2020; FDA lists 1 product record under event 84960, 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. 3% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 10 Jun 2020. 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., Princeton, NJ.
Reason for recall
"Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use."
Distribution
"Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX and countries of Italy, France, Germany, and Finland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1470-2020 | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. | 55 | Class III | Terminated | 18 Mar 2020 |
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: "Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use."
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: "Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX and countries of Italy, France, Germany, and Finland."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Jun 2020. "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.