Integra NeuraGen Nerve Guide Recalled for Quality Control Error
Integra LifeSciences is recalling 55 units of NeuraGen Nerve Guides because nonconforming product was mistakenly released for commercial use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the criteria for a Low severity score.
Plain-English summary
Integra LifeSciences Corp. is recalling 55 units of the NeuraGen Nerve Guide, 7mm diameter, 2cm length (Part number PNG72, Lot # 3388360). The product is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
The recall was initiated because nonconforming product, which had been dispositioned for rejection, was mistakenly released for commercial use. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The affected units were distributed worldwide, including in the US states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX, as well as in Italy, France, Germany, and Finland. Healthcare providers and patients should contact Integra LifeSciences Corp. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- 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.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Nerve Repair
- Hazard
- Affected units
- 55
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 3388360
Distribution
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