FDA-Device2019-12-04Class II
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 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
1729
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 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-0530-2020Don'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