Medical device recalls Moderate risk

Corin Ltd recalls Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner…

Recall date
July 28, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2606-2021
FDA classification
Class II
Brand / firm
Corin Ltd
Sold / distributed
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

Why it was recalled

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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 Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.

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