Medical device recalls Moderate risk

CORENTEC CO., LTD recalls LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

Recall date
March 29, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1934-2024
FDA classification
Class II
Brand / firm
CORENTEC CO., LTD
Sold / distributed
US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.

Why it was recalled

Due to unsupported 10 year expiration date.

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

What was recalled

LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

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