Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw

Recall date
January 10, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1220-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Domestic: None VA/DOD: None Foreign: Japan

Why it was recalled

The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

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

What was recalled

1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw

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