Straight Shank Drill Bit 4 recalled over sterility concerns

Recall date

May 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer Biomet, Inc. recalls Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.

Recall number

Z-3174-2017

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

Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.