Recalls / —
—#179711
Product
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.
- FDA product code
- JXI — Cuff, Nerve
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K011168
- Affected lot / code info
- Lot # 3388360
Why it was recalled
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
On February 7, 2020, the firm notified all impacted consignees by Urgent Voluntary Medical Device Recall letters. Customers were informed of the product issue. Customers were instructed to remove any affected product from service. Whether they have affected product on hand or not, customers should then fill out the acknowledgement form and return it to the recalling firm. If the customer has indicated that they have affected product on hand, Customer Service will contact them to arrange to have the product returned for a replacement or credit. Distributors were asked to remove product from further distribution and to forward recall notification to any affected customers. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 1100 Campus Rd, Princeton, New Jersey 08540-6650
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2020-02-07
- Terminated
- 2020-06-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #179711. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.