Recall Z-0529-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0529-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-08-21, terminated 2021-07-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Terminated: 2021-07-21
Firm location: Warsaw, IN, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.