FDA-Device2017-10-04Class II
ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.
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
1558 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3163-2017Don't want to check this manually?
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