Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, St…

Recall date
May 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3144-2017
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Why it was recalled

Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

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

What was recalled

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile

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