Integra LifeSciences recalls NeuraGen nerve guides with part number PNG72 due to nonconforming product mistakenly released for commercial use. Affected units include specific lot numbers.
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Integra LifeSciences is recalling NeuraGen nerve guides with part number PNG72 because they were mistakenly released for sale after being rejected as nonconforming. This means the product may not meet safety standards and could pose risks.
The product was rejected as nonconforming but was mistakenly released for sale. This means the item may not meet the required safety standards for medical use, though the specific risk is not detailed in the recall.
People who own or use the NeuraGen nerve guide with part number PNG72, particularly those who have purchased it for medical nerve repair procedures.
Check for the part number PNG72 on the product. The nerve guide is 7mm diameter and 2cm length. Lot number 3388360 is associated with this recall.
Look for the part number PNG72 and lot number 3388360 on the NeuraGen nerve guide.
The product was rejected as nonconforming but was mistakenly released for commercial use.
Check for the part number PNG72 and lot number 3388360. If you have the recalled item, contact Integra LifeSciences for guidance.
The recall states the product was nonconforming but does not specify injury risks. The hazard is not detailed enough to confirm serious risks.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1470-2020 — Integra Integra Hello, I own a Integra that is covered by recall Z-1470-2020 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
