Zimmer Biomet, Inc. recalls 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to fac…

Recall date

August 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0531-2020

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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.

Why it was recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.