Reported Mar 18, 2020 · Terminated
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated…
Integra LifeSciences Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
NeuraGen Nerve Guide7mm diameter2cm length
- Part number PNG72 - Product UsageNeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity
- Lot codes and dates
- Lot # 3388360
- Amount recalled
- 55
Where it was sold
Why it was recalled
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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