Recall Z-0594-2013— Zimmer, Inc.
Class I · Terminated
Class I FDA medical device recall by Zimmer, Inc., initiated 2012-11-12, terminated 2014-02-25. It names one FDA 510(k) clearance: K073202. Product: Zimmer Spine Ardis Inserter, Rx, non-sterile. Reason: 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.
- Recalling firm
- Zimmer, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-11-12
- Terminated
- 2014-02-25
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.