Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Zimmer Spine Ardis Inserter Recalled by Zimmer, Inc. Due to Zimmer Spine has received reports of the PEEK...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.
Affected Products
Zimmer Spine Ardis Inserter, Rx, non-sterile
Quantity: 315 (172 in USA)
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer, Inc.
Zimmer, Inc. has 437 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report