The NeuraGen Nerve Guide, part number PNG720, had one lot released that was out of specification for a finished goods release test. Because it did not meet the criteria required for a release, Integra decided to initiate a voluntary recall of the impacted product.
Integra has not received any complaints regarding the product, and no serious injuries and/or deaths have occurred due to the failure mode associated with the recall.
According to the safety notice, the severity of harm has been assessed to be negligible. Medical and science personnel deemed the failure to cause no immediate or long-term health impact.
Time-based shelf-life predictive analysis showed that the product was likely within the required range at the time of release and subsequent use, which indicates that no product failure would occur and no performance issues are anticipated for the progressive recovery of nerves being treated with the NeuraGen Nerve Guide.
The affected products came from lot 3388360 and were manufactured/distributed on Jan. 18, 2019, with an expiration date of Jan. 31, 2021. Integra said to mitigate the risk, users should identify the device, quarantine it and return it to the company.
Integra said it does not recommend explantation for the issue, but out of an abundance of caution, it chose to recall the lone lot of impacted nerve guides. No other products were impacted and should be used with confidence, according to the company.