Medical device recalls Moderate risk

Biomet, Inc. recalls Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

Recall date
January 9, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1122-2015
FDA classification
Class II
Brand / firm
Biomet, Inc.
Sold / distributed
Distributed in the states of VA and TX and the country of Japan.

Why it was recalled

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

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

What was recalled

Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

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