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Zimmer Biomet, Inc. recalls GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems
Recalled December 4, 2019 · FDA recall Z-0529-2020 · Zimmer Biomet
Hazard
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. · FDA Class II
Units
2468
Sold at
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.
Description
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Product
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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →