Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls JS Series SterilContainer S2 System

Recall date
September 8, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0624-2018
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
Nationally

Why it was recalled

The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

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

What was recalled

JS Series SterilContainer S2 System

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