FDA-Device2019-12-04Class II
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - 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
2708
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - 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-0531-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief