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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