Medical device recalls Moderate risk

Corin Ltd recalls Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

Recall date
November 8, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0726-2023
FDA classification
Class II
Brand / firm
Corin Ltd
Sold / distributed
US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.

Why it was recalled

The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.

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

What was recalled

Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

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