Medical device recalls Moderate risk

Signature Orthopedics Pty Limited product recalled over labeling errors

Recall date
April 20, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Signature Orthopedics Pty Limited recalls Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implan…
Recall number
Z-1694-2021
FDA classification
Class II
Brand / firm
Signature Orthopedics Pty Limited
Sold / distributed
US Nationwide distribution in the state of NC.

Why it was recalled

Product mislabeled, with the incorrect product inside the package.

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

What was recalled

Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

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