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Recall

Class II — Integra LifeSciences Corp.

Recalling firmIntegra LifeSciences Corporation
Registered facilityView this company's 15 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonVoluntary 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.
ProductPanta Nail, Rx only, Sterile,
Quantity4,449 units
DistributionUS Nationwide and Internationally
Initiated2017-03-03
Classified2017-03-23
Terminated2018-05-21
Recall numberZ-1539-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-1539-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76693/

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