FDA-Device2017-03-29Class II

Panta Nail, Rx only, Sterile,

Integra LifeSciences Corp.
Hazard

Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

Sold states
US Nationwide and Internationally
Affected count
4,449 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
Panta Nail, Rx only, Sterile,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2017

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