FDA-Device2017-10-04Class II

Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile

Zimmer Biomet, Inc.
Hazard

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.

Sold states
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Affected count
18 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3145-2017

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