NeuraGen Nerve Guide — Class III medical device recall Z-1470-2020
Terminated recall by Integra LifeSciences Corp., reported 2020-03-18, distributed nationwide. Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
| Recall number | Z-1470-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2020-02-07 |
| Classified | 2020-03-11 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2020-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FI, FR, IT |
| Quantity | 55 |
| Lot numbers | 3388360 |
| Model numbers | PNG72 |
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.
Reason for recall
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1470-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.