Medical device recalls Moderate risk

Integra LifeSciences Corp. recalls Panta Nail, Rx only, Sterile,

Recall date
March 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1539-2017
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
US Nationwide and Internationally

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Panta Nail, Rx only, Sterile,

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