FDA-Device2019-12-04Class II
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Zimmer Biomet, Inc.
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Sold states
US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
Affected count
2468
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2020Don't want to check this manually?
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