Zimmer Spine Ardis Inserter, Rx, non-sterile
Reported: January 2, 2013 Initiated: November 12, 2012 #Z-0594-2013
Product Description
Zimmer Spine Ardis Inserter, Rx, non-sterile
Reason for Recall
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
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 315 (172 in USA)
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Zimmer Spine Ardis Inserter, Rx, non-sterile. Recalled by Zimmer, Inc.. Units affected: 315 (172 in USA).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2013. Severity: Critical. Recall number: Z-0594-2013.
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