FDA-Device2013-01-02Class I
Zimmer Spine Ardis Inserter, Rx, non-sterile
Zimmer, Inc.
Hazard
Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks
Sold states
Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore.
Affected count
315 (172 in USA)
Manufactured in
345 E Main St, N/A, Warsaw, IN, United States
Products
Zimmer Spine Ardis Inserter, Rx, non-sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2013Don't want to check this manually?
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